prevention of diabetic foot ulcers and lower extremity amputation

1. PREVENTION OF DIABETIC FOOT ULCERS AND LOWER EXTREMITY AMPUTATION Barry Stults, M.D. Scott Clark, D.P.M Thomas Miller, M.D. University of Utah Medical Center

2. CASE: Mr. M.C. 64 yr-old obese white male, not seen x 12 mo Type 2 DM (15 yrs) BP ? (18 yrs) Dyslipidemia (18 yrs) CABG (10 yrs ago) Claudication (today; 25 yds) Insulin/Metformin/Statin/ARB/Hctz/CCB/ASA �Sore on my left foot, Doc� Mr. M.C. is a 64 year-old obese white male who had not been seen in primary care clinic for 12 months because he had missed multiple appointments. He had type 2 diabetes for 15 years, hypertension and dyslipidemia for 18 years, and coronary artery bypass grafting 10 years ago. On this particular visit he also noted left calf claudication on walking 25 yards that had been present for several months. He had been prescribed multiple medications although he had not refilled them for the past six months. What really brought him to clinic on this particular day was an ulcer on his left heel. Mr. M.C. is a 64 year-old obese white male who had not been seen in primary care clinic for 12 months because he had missed multiple appointments. He had type 2 diabetes for 15 years, hypertension and dyslipidemia for 18 years, and coronary artery bypass grafting 10 years ago. On this particular visit he also noted left calf claudication on walking 25 yards that had been present for several months. He had been prescribed multiple medications although he had not refilled them for the past six months. What really brought him to clinic on this particular day was an ulcer on his left heel.

3. This is Mr. M.C.�s left heel ulcer. Note the maggots infesting � but perhaps also debriding � this wound. This is Mr. M.C.�s left heel ulcer. Note the maggots infesting � but perhaps also debriding � this wound.

4. CASE: Mr. M.C. Clinical evaluation of heel ulcer: Probe reached bone Extensive subcutaneous abscess MRI: extensive osteomyelitis ABI: 0.2 Angiography: severe infrapopliteal, suprapopliteal obstruction Not amenable to revascularization Uncontrolled infection despite antibiotics/drainage Using a sterile metallic probe, the clinic podiatrist explored the wound. The probe easily reached bone indicating a high likelihood of osteomyelitis. Extensive subcutaneous abscess formation was also apparent. The patient was admitted to the hospital where an MRI study of the left foot confirmed extensive osteomyelitis of the calcaneous. No pedal pulses were present in the left foot, and a left leg ankle-brachial index study performed the day of admission showed an ABI=0.2 indicating critical ischemia. Vascular surgery consultation was obtained and angiography was recommended. Unfortunately, this revealed severe suprapopliteal and infrapopliteal obstruction at multiple levels which the vascular surgeons felt was not amenable to revascularization. Despite parenteral antibiotics and several drainage procedures, the infection remained uncontrolled. A below-the-knee amputation was required. Using a sterile metallic probe, the clinic podiatrist explored the wound. The probe easily reached bone indicating a high likelihood of osteomyelitis. Extensive subcutaneous abscess formation was also apparent. The patient was admitted to the hospital where an MRI study of the left foot confirmed extensive osteomyelitis of the calcaneous. No pedal pulses were present in the left foot, and a left leg ankle-brachial index study performed the day of admission showed an ABI=0.2 indicating critical ischemia. Vascular surgery consultation was obtained and angiography was recommended. Unfortunately, this revealed severe suprapopliteal and infrapopliteal obstruction at multiple levels which the vascular surgeons felt was not amenable to revascularization. Despite parenteral antibiotics and several drainage procedures, the infection remained uncontrolled. A below-the-knee amputation was required.

6. AMPUTATIONS IN DIABETES Common: Worldwide � amputation 2? to diabetes q 30 sec. U.S.A. � 80,000 amputations/y (2002) Higher rates in men, racial/ethnic minorities Costly: $60,000/amputation $2 billion/y total costs Lancet 2005; 366:1719 Diabetes Care 2004; 27:1598 Diabetes Care 2003; 26:495 Unfortunately, cases like this are all too common. Worldwide, there is an amputation secondary to diabetes every 30 seconds, and there are at least 80,000 amputations/year in the United States. Amputation rates are higher in men and in members of racial and ethnic minority groups, particularly Native-Americans and Hispanic-Americans. Amputations are costly at $60,000/case, resulting in a total cost to U.S. healthcare payers of $2 billion/y.Unfortunately, cases like this are all too common. Worldwide, there is an amputation secondary to diabetes every 30 seconds, and there are at least 80,000 amputations/year in the United States. Amputation rates are higher in men and in members of racial and ethnic minority groups, particularly Native-Americans and Hispanic-Americans. Amputations are costly at $60,000/case, resulting in a total cost to U.S. healthcare payers of $2 billion/y.

7. AMPUTATIONS IN DIABETES Tragic: �Rule of 50� 50% of amputations transfemoral/transtibial level 50% of patients 2nd amputation in ? 5y 50% of patients Die in ? 5y Clinical Care of the Diabetic Foot, 2005 However, more important than expense, amputations have tragic consequences for the individual that can be summarized by the �Rule of 50�: 50% of diabetic amputations occur at the very disabling transfemoral or transtibial levels. 50% of these patients will require a second amputation within just 5 years. 50% of these patients will die within 5 years, most from concurrent coronary artery disease or cerebrovascular disease.However, more important than expense, amputations have tragic consequences for the individual that can be summarized by the �Rule of 50�: 50% of diabetic amputations occur at the very disabling transfemoral or transtibial levels. 50% of these patients will require a second amputation within just 5 years. 50% of these patients will die within 5 years, most from concurrent coronary artery disease or cerebrovascular disease.

8. FOOT ULCERS IN DIABETES Precipitate 85% of amputations: �Rule of 15� 15% of diabetes patients Foot ulcer in lifetime 15% of foot ulcers Osteomyelitis 15% of foot ulcers Amputation Clinical Care of the Diabetic Foot, 2005 Foot ulcers precipitate about 85% of diabetic amputations. Key epidemiologic points about diabetic foot ulcer can be summarized by the �Rule of 15�: 15% of diabetes patients will experience a foot ulcer during their lifetime. 15% of these foot ulcers will progress to osteomyelitis. Even with optimal multidisciplinary care, 15% of diabetic foot ulcers will result in a lower extremity amputation at some level. Foot ulcers precipitate about 85% of diabetic amputations. Key epidemiologic points about diabetic foot ulcer can be summarized by the �Rule of 15�: 15% of diabetes patients will experience a foot ulcer during their lifetime. 15% of these foot ulcers will progress to osteomyelitis. Even with optimal multidisciplinary care, 15% of diabetic foot ulcers will result in a lower extremity amputation at some level.

9. FOOT ULCERS IN DIABETES Costly: $30,000/ulcer $9 billion/y total costs Tragic: Quality of life: ulcer patient ? amputation patient Burden of non-weight-bearing as ulcer heals Lifetime behavioral adaptations to prevent recurrence Fear of recurrent ulcer/amputation 70% ulcer recurrence in ? 3y Foot Ankle Int 2005; 26:32, 128 Clin Infect Dis 2004; 39(Suppl 2):S129 Diabetic foot ulcers are very costly at $30,000/ulcer with a net cost to U.S. healthcare payers of $9 billion/year. However, more important are the tragic personal consequences of a diabetic foot ulcer. The health-related quality of life of a patient with a diabetic foot ulcer may be less than that of a patient with an amputation. These persons must initially suffer the burden of non-weight-bearing for the several months or longer required for ulcer healing. They must look forward to a lifetime of behavioral adaptations necessary to prevent ulcer recurrence. But most of all, they must live with the constant fear of recurrent ulceration and possible amputation � a very real fear as there is a 70% risk of ulcer recurrence within just 3 years. Diabetic foot ulcers are very costly at $30,000/ulcer with a net cost to U.S. healthcare payers of $9 billion/year. However, more important are the tragic personal consequences of a diabetic foot ulcer. The health-related quality of life of a patient with a diabetic foot ulcer may be less than that of a patient with an amputation. These persons must initially suffer the burden of non-weight-bearing for the several months or longer required for ulcer healing. They must look forward to a lifetime of behavioral adaptations necessary to prevent ulcer recurrence. But most of all, they must live with the constant fear of recurrent ulceration and possible amputation � a very real fear as there is a 70% risk of ulcer recurrence within just 3 years.

10. TEAM CARE REDUCES ULCERS/AMPUTATIONS Five clinical trials: Format: integrated, risk-stratified interventions ID high-risk patients with exam: Frequent follow-up to detect early problems Educate/motivate self-care behaviors Prophylactic nail/skin care by podiatry Therapeutic footwear, if needed Prompt, multidisciplinary Rx of ulcers Lancet 2005; 366:1676 Fortunately, five clinical trials have demonstrated that multidisciplinary team care can significantly reduce diabetic ulcer and amputation rates. These trials all included integrated, risk-stratified interventions. The first step in these programs was to identify patients at high-risk for foot ulceration by history and physical examination. High risk patients were then targeted with special interventions. They had frequent followup to detect early foot problems. They were intensively educated � and hopefully motivated - to perform self-foot care behaviors. They had regular prophylactic nail and skin care by podiatrists, and if needed, they were provided with therapeutic footwear. The second essential step in these programs was prompt, multidisciplinary treatment of any foot ulcers that occurred despite attempts at prevention.Fortunately, five clinical trials have demonstrated that multidisciplinary team care can significantly reduce diabetic ulcer and amputation rates. These trials all included integrated, risk-stratified interventions. The first step in these programs was to identify patients at high-risk for foot ulceration by history and physical examination. High risk patients were then targeted with special interventions. They had frequent followup to detect early foot problems. They were intensively educated � and hopefully motivated - to perform self-foot care behaviors. They had regular prophylactic nail and skin care by podiatrists, and if needed, they were provided with therapeutic footwear. The second essential step in these programs was prompt, multidisciplinary treatment of any foot ulcers that occurred despite attempts at prevention.

11. TEAM CARE REDUCES ULCERS/AMPUTATIONS Efficacy of team care: 50-80% reductions in ulcers/amputations Economic modeling studies of team care: Cost-effective if 25-40% reduction in ulcer rate Cost-saving if > 40% reduction in ulcer rate Applicable only to high-risk patients Lancet 2005; 366:1719 Diabetes Care 2004; 27:901 These trials demonstrated 50-80% reductions in ulcer and amputation rates. Economic modeling studies have suggested that such programs are cost-effective if they reduce ulcer/amputation rates 25-40% and may even be cost-saving if greater reductions are possible, provided that the programs include only those patients with risk factors for diabetic foot ulceration.These trials demonstrated 50-80% reductions in ulcer and amputation rates. Economic modeling studies have suggested that such programs are cost-effective if they reduce ulcer/amputation rates 25-40% and may even be cost-saving if greater reductions are possible, provided that the programs include only those patients with risk factors for diabetic foot ulceration.

12. Sensory ? Joint Motor Autonomic PAD Neuropathy Mobility Neuropathy Neuropathy Protective Muscle atrophy and ? Sweating Ischemia sensation 2� foot deformities 2� dry skin Foot pressure ? Foot pressure Fissure ? Healing Minor trauma esp. over recognition bony prominences Callus Pre-ulcer ULCER Infection AMPUTATION Minor Trauma: Interdigital Maceration Mechanical (Moisture, Fungus) Chemical Thermal What are the central pathogenetic factors leading to diabetic foot ulcer and subsequent amputation? Sensory neuropathy leads to a loss of protective sensation in the feet with two consequences: increased foot pressure over bony prominences contributing to callus formation; and decreased ability to recognize and then eliminate exposure to minor trauma. Diabetic motor neuropathy leads to atrophy of the intrinsic musculature of the foot with subsequent foot deformities; in turn, these foot deformities increase foot pressure over bony prominences and result in callus formation. Alterations in connective tissue induced by diabetes reduce joint mobility, particularly dorsiflexion of the ankle and the first metatarsophalangeal joint, again augmenting foot pressure over bony prominences and resulting in callus formation. Callus increases the subcutaneous pressure beneath it and can lead to subcutaneous hemorrhage. The resulting lesion � callus with subcutaneous hemorrhage � is called a �pre-ulcer� because continued pressure on the lesion for a matter of days can cause frank ulceration. There are other mechanisms of foot ulceration in persons with diabetes. Autonomic neuropathy leads to reduced sweating and excessively dry skin which can fissure and ulcerate. Interdigital maceration from excessive moisture and secondary fungal infection can cause ulceration in the interdigital spaces and on the sides of the toes. Finally, mechanical, chemical, or thermal trauma facilitated by the loss of protective sensation can directly damage the skin and cause ulceration. Peripheral arterial disease and subsequent ischemia can create an ischemic foot ulcer, but this is a relatively uncommon mechanism of ulcer formation in diabetes. Instead, the greater importance of peripheral arterial ischemia is to delay ulcer healing and facilitate secondary infection and its progression, a major contributor to eventual lower extremity amputation. What are the central pathogenetic factors leading to diabetic foot ulcer and subsequent amputation? Sensory neuropathy leads to a loss of protective sensation in the feet with two consequences: increased foot pressure over bony prominences contributing to callus formation; and decreased ability to recognize and then eliminate exposure to minor trauma. Diabetic motor neuropathy leads to atrophy of the intrinsic musculature of the foot with subsequent foot deformities; in turn, these foot deformities increase foot pressure over bony prominences and result in callus formation. Alterations in connective tissue induced by diabetes reduce joint mobility, particularly dorsiflexion of the ankle and the first metatarsophalangeal joint, again augmenting foot pressure over bony prominences and resulting in callus formation. Callus increases the subcutaneous pressure beneath it and can lead to subcutaneous hemorrhage. The resulting lesion � callus with subcutaneous hemorrhage � is called a �pre-ulcer� because continued pressure on the lesion for a matter of days can cause frank ulceration. There are other mechanisms of foot ulceration in persons with diabetes. Autonomic neuropathy leads to reduced sweating and excessively dry skin which can fissure and ulcerate. Interdigital maceration from excessive moisture and secondary fungal infection can cause ulceration in the interdigital spaces and on the sides of the toes. Finally, mechanical, chemical, or thermal trauma facilitated by the loss of protective sensation can directly damage the skin and cause ulceration. Peripheral arterial disease and subsequent ischemia can create an ischemic foot ulcer, but this is a relatively uncommon mechanism of ulcer formation in diabetes. Instead, the greater importance of peripheral arterial ischemia is to delay ulcer healing and facilitate secondary infection and its progression, a major contributor to eventual lower extremity amputation.

13. OTHER RISKS FOR ULCER/AMPUTATION Failure to adequately care for the feet: Inadequate patient education Inadequate patient motivation Depression, anxiety, anger more common in diabetes Physical disability Cannot see feet 2? to retinopathy Cannot reach feet 2? to obesity, age (?50% of patients) Limited access to podiatry services Age Ageing 1992; 21:333 Diabetes Care 2003; 29:495 Diab Metab Res Rev 2004; 20(Suppl 1):S13 Another risk factor for foot ulcer and amputation is poor self-foot care practices by the patient. Failure to adequately care for one�s feet may result from psychological or physical disability or from inadequate patient education. Depression, anxiety, and maladaptive anger are all two-fold more common in the diabetic population and may reduce motivation to care for the feet. Cognitive dysfunction and dementia may be 2-fold more common in elderly persons who have type 2 diabetes. Physical disability may also contribute to poor self-foot care practices as some patients cannot adequately see their feet due to retinopathy, while up to 50% of diabetic patients cannot reach their feet to see or care for them because of obesity and/or advanced age. Many diabetic patients are never adequately educated about foot care. Limited access to podiatric services in rural or low-income areas may also be a risk factor for diabetic foot ulceration. Another risk factor for foot ulcer and amputation is poor self-foot care practices by the patient. Failure to adequately care for one�s feet may result from psychological or physical disability or from inadequate patient education. Depression, anxiety, and maladaptive anger are all two-fold more common in the diabetic population and may reduce motivation to care for the feet. Cognitive dysfunction and dementia may be 2-fold more common in elderly persons who have type 2 diabetes. Physical disability may also contribute to poor self-foot care practices as some patients cannot adequately see their feet due to retinopathy, while up to 50% of diabetic patients cannot reach their feet to see or care for them because of obesity and/or advanced age. Many diabetic patients are never adequately educated about foot care. Limited access to podiatric services in rural or low-income areas may also be a risk factor for diabetic foot ulceration.

14. CAUSAL PATHWAYS FOR FOOT ULCERS % Causal Pathways NEUROPATHY Neuropathy: 78% ? Minor trauma: 79% DEFORMITY Deformity: 63% ? Behavioral issues ? MINOR TRAUMA - Mechanical (shoes) POOR SELF- - Thermal FOOT CARE - Chemical ULCER Diabetes Care 1999; 22:157 Prospective studies have investigated the causal pathways leading to diabetic foot ulcer. The most common pathway involved a combination of sensory neuropathy, foot deformities secondary to motor neuropathy, and minor trauma caused by poor self-foot care practices. Sources of minor trauma included ill-fitting shoes, thermal trauma (hot water, sand, or pavement) and chemical trauma (over-the-counter corn plasters).Prospective studies have investigated the causal pathways leading to diabetic foot ulcer. The most common pathway involved a combination of sensory neuropathy, foot deformities secondary to motor neuropathy, and minor trauma caused by poor self-foot care practices. Sources of minor trauma included ill-fitting shoes, thermal trauma (hot water, sand, or pavement) and chemical trauma (over-the-counter corn plasters).

15. DETECTING FEET-AT-RISK History: Prior amputation Prior foot ulcer PAD: known or claudication at < 1 block Exam: Insensate to 5.07/10g monofilament Major foot deformities PAD Absent DP and PT pulses Prolonged venous filling time Reduced Ankle-Brachial Index (ABI) Pre-ulcerative cutaneous pathology Arch Intern Med 1998; 158:157 Diabetic patients with feet-at-risk for ulceration and amputation can be detected and risk-stratified using just three historical and four examination features. Key historical features include a prior history of lower extremity amputation or foot ulcer and a history of known peripheral arterial disease or clinical claudication on walking less than one block. Key examination features include inability to sense the 5.07/10g monofilament, major foot deformities,and peripheral arterial disease diagnosed by absent pedal pulses, a prolonged venous filling time, or by a reduced Ankle-Brachial Index. Although not part of the most commonly used risk stratification scheme, pre-ulcer cutaneous pathology also identifies feet-at-risk for ulcer and amputationDiabetic patients with feet-at-risk for ulceration and amputation can be detected and risk-stratified using just three historical and four examination features. Key historical features include a prior history of lower extremity amputation or foot ulcer and a history of known peripheral arterial disease or clinical claudication on walking less than one block. Key examination features include inability to sense the 5.07/10g monofilament, major foot deformities,and peripheral arterial disease diagnosed by absent pedal pulses, a prolonged venous filling time, or by a reduced Ankle-Brachial Index. Although not part of the most commonly used risk stratification scheme, pre-ulcer cutaneous pathology also identifies feet-at-risk for ulcer and amputation

16. RISK STRATIFY FOR FOOT ULCERATION Foot Ulcer, % Office Patients Risk Level %/yr (diabetes clinics) 3: prior amputation 28.1% 7% prior ulcer 18.6% 2: insensate 6.3% 10% and foot deformity or absent pedal pulses 1: insensate 4.8% 17 - 30% 0: all normal 1.7% 66% Diabetes Care 2001; 24:1442 Diabetes Metab 2003; 29:261 Diabetic patients can be stratified into one of four risk levels for subsequent foot ulceration. Risk level 3 patients with either a prior lower extremity amputation or foot ulcer are at greatest risk as their annual risk of foot ulceration is 18-28%; fortunately, only about 7% of office patients are at this level of risk. Risk level 2 patients are insensate to the 10g monofilament, and in addition, they have either major foot deformities or absent pedal pulses; their annual risk of foot ulcer is about 6%. Risk level 1 patients are insensate to the 10g monofilament as their only risk factor; they have a 4.8%/year risk of foot ulcer, and they comprise 17-30% of the diabetic patients seen in the office practice. Note that risk level 0 patients who have none of these risk factors may still have an increased risk of foot ulceration of 1-2%/year. Diabetic patients can be stratified into one of four risk levels for subsequent foot ulceration. Risk level 3 patients with either a prior lower extremity amputation or foot ulcer are at greatest risk as their annual risk of foot ulceration is 18-28%; fortunately, only about 7% of office patients are at this level of risk. Risk level 2 patients are insensate to the 10g monofilament, and in addition, they have either major foot deformities or absent pedal pulses; their annual risk of foot ulcer is about 6%. Risk level 1 patients are insensate to the 10g monofilament as their only risk factor; they have a 4.8%/year risk of foot ulcer, and they comprise 17-30% of the diabetic patients seen in the office practice. Note that risk level 0 patients who have none of these risk factors may still have an increased risk of foot ulceration of 1-2%/year.

17. ANNUAL DIABETIC FOOT EXAMS2000 Behavioral Risk Factor Surveillance System, CDC Unfortunately, too few annual diabetic foot examinations are completed in the U.S., and so risk stratification does not occur. In the year 2000 only 63% of diabetic persons reported having had a foot exam in the past year. Foot examination rates were significantly higher in the VA healthcare system, and as expected, significantly lower in diabetic persons with no health insurance.Unfortunately, too few annual diabetic foot examinations are completed in the U.S., and so risk stratification does not occur. In the year 2000 only 63% of diabetic persons reported having had a foot exam in the past year. Foot examination rates were significantly higher in the VA healthcare system, and as expected, significantly lower in diabetic persons with no health insurance.

18. PHYSICAL EXAMINATION OF THE FEET IN PERSONS WITH DIABETES Let�s review the key components of the physical examination of the feet in persons with diabetes mellitus.Let�s review the key components of the physical examination of the feet in persons with diabetes mellitus.

19. SENSORY NEUROPATHY IN DIABETES Loss of protective sensation in feet Sensory loss sufficient to allow painless skin injury Major risk factor for foot ulcer in diabetes Detect with 5.07/10g Semmes-Weinstein monofilament Prevalence of insensate feet to 10g monofilament: Age > 40y: 30% of diabetic patients Age > 60y: 50% of diabetic patients Up to 50% have no neuropathic symptoms Diabetes Care 2006; 29(Suppl 1):S24 Diabetes Care 2004; 27:1591 Sensory neuropathy from diabetes can lead to a loss of protective sensation in the feet sufficient to allow painless skin injury, and as such is a major risk factor for foot ulcer and amputation. This loss of protective sensation can be quickly and accurately detected using the 5.07/10 gram Semmes-Weinstein monofilament. Recent studies suggest that among persons with diabetes the prevalence of insensate feet to the 10g monofilament is 30% over age 40 years and 50% over age 60 years. Up to 50% of these persons are asymptomatic with respect to neuropathic symptoms. Sensory neuropathy from diabetes can lead to a loss of protective sensation in the feet sufficient to allow painless skin injury, and as such is a major risk factor for foot ulcer and amputation. This loss of protective sensation can be quickly and accurately detected using the 5.07/10 gram Semmes-Weinstein monofilament. Recent studies suggest that among persons with diabetes the prevalence of insensate feet to the 10g monofilament is 30% over age 40 years and 50% over age 60 years. Up to 50% of these persons are asymptomatic with respect to neuropathic symptoms.

20. The monofilament is imbedded in a plastic handle, a sturdy piece of cardboard, or a pen-like device. The cardboard monofilaments are disposable but can be reused. Four suppliers of accurate monofilaments are listed in the Tool-Kit. The accuracy of monofilaments provided by some pharmaceutical companies is unknown. The monofilament is imbedded in a plastic handle, a sturdy piece of cardboard, or a pen-like device. The cardboard monofilaments are disposable but can be reused. Four suppliers of accurate monofilaments are listed in the Tool-Kit. The accuracy of monofilaments provided by some pharmaceutical companies is unknown.

21. When the 5.07/10g monofilament is bowed into a C-shape for one second, approximately 10 grams of force are applied at the site of contact. When the 5.07/10g monofilament is bowed into a C-shape for one second, approximately 10 grams of force are applied at the site of contact.

22. UTILITY OF MONOFILAMENT TESTING Predicts ulcer/amputation in 5 prospective studies: NPV (normal sensing) = 90-98% PPV (fail to sense) = 18-36% Prospective 32 mo observational study: 80% of ulcers/100% of amputations in insensate feet Superior predictive value to other tests: Pin prick, cotton wisp, symptoms ? 128 Hz tuning fork? ADA recommendation, 2006: also test vibration Diabetes Care 2006; 29(Suppl 1):S25 J Fam Pract 2000; 49:S30 Diabetes Care 1992; 15:1386 Testing for sensory neuropathy with the 5.07/10g monofilament has been demonstrated to predict ulcer and amputation risk in five prospective studies. For foot ulceration, the negative predictive value of normal sensing varied from 90-98%, that is, only a small percentage of patients who can sense the monofilament will develop a foot ulcer. On the other hand, the positive predictive value for foot ulcer of failure to sense the monofilament was 18-36%, that is, 18-36% of the patients who could not feel the monofilament developed an ulcer. In a prospective 32 month observational study, 80% of foot ulcers and 100% of amputations occurred in patients with insensate feet to the 5.07/10g monofilament. Monofilament testing has superior predictive value as compared to other test modalities such as the 128Hz tuning fork, pin-prick, cotton wisps, or the presence or absence of neuropathic symptoms. Testing for sensory neuropathy with the 5.07/10g monofilament has been demonstrated to predict ulcer and amputation risk in five prospective studies. For foot ulceration, the negative predictive value of normal sensing varied from 90-98%, that is, only a small percentage of patients who can sense the monofilament will develop a foot ulcer. On the other hand, the positive predictive value for foot ulcer of failure to sense the monofilament was 18-36%, that is, 18-36% of the patients who could not feel the monofilament developed an ulcer. In a prospective 32 month observational study, 80% of foot ulcers and 100% of amputations occurred in patients with insensate feet to the 5.07/10g monofilament. Monofilament testing has superior predictive value as compared to other test modalities such as the 128Hz tuning fork, pin-prick, cotton wisps, or the presence or absence of neuropathic symptoms.

23. USING THE 5.07/10gm MF (Tool-Kit) Demonstrate sensation on the forearm or hand Place monofilament perpendicular to test site Bow into C-shape for one second Test four sites/foot: Predicts 95% of ulcer formers vs. 8 sites Heel testing does not discriminate ulcer formers Avoid calluses, scars, and ulcers Test with the monofilament using the following protocol: Place the patient in the supine position with shoes and socks removed. Demonstrate sensation of the filament on the patient�s forearm or hand, bowing the monofilament into a C-shape for one second. Ask the patient to close their eyes. Proceed to bow the monofilament into a C-shape for one second at each of four test sites on the plantar surface of each foot: the plantar surface of the distal phalanx of the great toe and the plantar surfaces of the 1st, 3rd, and 5th metatarsal heads. In one study testing these four sites as compared to eight sites still detected 95% of ulcer formers; in particular, heel testing does not discriminate ulcer formers. Avoid testing calluses, scars, or ulcers; if these lesions are present, test at adjacent sites on the plantar surface of the foot. Test with the monofilament using the following protocol: Place the patient in the supine position with shoes and socks removed. Demonstrate sensation of the filament on the patient�s forearm or hand, bowing the monofilament into a C-shape for one second. Ask the patient to close their eyes. Proceed to bow the monofilament into a C-shape for one second at each of four test sites on the plantar surface of each foot: the plantar surface of the distal phalanx of the great toe and the plantar surfaces of the 1st, 3rd, and 5th metatarsal heads. In one study testing these four sites as compared to eight sites still detected 95% of ulcer formers; in particular, heel testing does not discriminate ulcer formers. Avoid testing calluses, scars, or ulcers; if these lesions are present, test at adjacent sites on the plantar surface of the foot.

24. USING THE 5.07/10g MF (Tool-Kit) Minimize bias: Test sites in random sequences Test each site X3, sham test as 1 of 3 Do you feel it? Yes or No? Retest site if patient fails (misses 2/3 responses) Insensate at 1 site = insensate feet Falsely insensate with edema, cold feet Test annually when sensation normal Use < 100x/d; replace if bent; replace q 3 mo. Purchase calibrated MF (See Tool-Kit) To minimize bias, test the different sites in random sequences and test each site three times: two real tests and one sham test. Say to the patient: �I am going to touch the bottom of your feet at different times with the filament. When I ask you if you feel it now, just answer yes or no.� A patient fails at a particular site if they are incorrect for two of the three responses. If the patient fails at a particular site, retest it once more later in the exam. If they fail the second time, they are diagnosed as insensate: inability to accurately sense the monofilament at just one site on one foot still diagnoses the patient as having insensate feet. Cold or edematous feet may be falsely insensate. If patients accurately sense the monofilament, they should be tested annually; if they are insensate, retesting annually is not necessary, although some clinicians choose to do so to remind the patient of this important deficit. The monofilament should be used for less than 100 applications per 24 hours; more frequent use fatigues the filament so that it no longer applies 10g of force, and it should then be rested for 24 hours. In general, monofilaments should be replaced every three months, or immediately if they are bent. To minimize bias, test the different sites in random sequences and test each site three times: two real tests and one sham test. Say to the patient: �I am going to touch the bottom of your feet at different times with the filament. When I ask you if you feel it now, just answer yes or no.� A patient fails at a particular site if they are incorrect for two of the three responses. If the patient fails at a particular site, retest it once more later in the exam. If they fail the second time, they are diagnosed as insensate: inability to accurately sense the monofilament at just one site on one foot still diagnoses the patient as having insensate feet. Cold or edematous feet may be falsely insensate. If patients accurately sense the monofilament, they should be tested annually; if they are insensate, retesting annually is not necessary, although some clinicians choose to do so to remind the patient of this important deficit. The monofilament should be used for less than 100 applications per 24 hours; more frequent use fatigues the filament so that it no longer applies 10g of force, and it should then be rested for 24 hours. In general, monofilaments should be replaced every three months, or immediately if they are bent.

25. PAD IN DIABETES Prevalence (ABI < 0.9): 20-30% 10-20% in type 2 diabetes at Dx 30% in diabetics ? age 50y 40-60% in diabetics with foot ulcer Complications: Claudication and functional disability Increases risk for concurrent CAD and CVD Delays ulcer healing Increases amputation risk Not increase foot ulcer risk JACC 2006; 47:921 Diabet Med 2005; 22:1310 Diabetes Care 2003; 26:3333 Defined as an Ankle-Brachial Index (ABI) < 0.9, PAD has a prevalence of 20-30% in patients with diabetes: 10-20% at the time of diagnosis in type 2 diabetes, 30% in diabetic patients over age 50, and 40-60% in diabetic patients with a concurrent foot ulcer. While PAD can cause claudication and consequent functional disability and increases the risk of concurrent coronary artery disease and cerebrovascular disease, it also delays the healing of foot ulcers, facilitates secondary infection, and is a major risk factor for lower extremity amputation. PAD is not an independent risk factor for foot ulcer in diabetes. Defined as an Ankle-Brachial Index (ABI) < 0.9, PAD has a prevalence of 20-30% in patients with diabetes: 10-20% at the time of diagnosis in type 2 diabetes, 30% in diabetic patients over age 50, and 40-60% in diabetic patients with a concurrent foot ulcer. While PAD can cause claudication and consequent functional disability and increases the risk of concurrent coronary artery disease and cerebrovascular disease, it also delays the healing of foot ulcers, facilitates secondary infection, and is a major risk factor for lower extremity amputation. PAD is not an independent risk factor for foot ulcer in diabetes.

26. HX TO DETECT PAD IN DIABETES Claudication at < 1 block suggests severe ischemia Vascular Level Site of Pain Aorto-iliac Buttocks/Thigh Femoral Calf Tibioperoneal Foot/Ankle Rest pain indicates critical ischemia Toes and forefoot Difficult to distinguish from neuropathic pain A history of claudication is relatively specific but not sensitive for the diagnosis of PAD. Perhaps 70% of patients with PAD do not have classic intermittent claudication, and 20-48% are entirely asymptomatic. Claudication on walking less than one block implies severe ischemia and can be localized to one of three vascular levels: buttock/thigh claudication to aorto-iliac obstruction, calf claudication to femoral-popliteal artery obstruction, and the less commonly recognized foot/ankle claudication to tibioperoneal artery obstruction. Note that there is a relative predominance of femoral-popliteal and tibioperoneal vascular disease in persons with diabetes with relative sparing of the pedal arteries. Rest pain signals critical ischemia. It occurs in the toes and forefoot where it can be difficult to distinguish from neuropathic pain. A history of claudication is relatively specific but not sensitive for the diagnosis of PAD. Perhaps 70% of patients with PAD do not have classic intermittent claudication, and 20-48% are entirely asymptomatic. Claudication on walking less than one block implies severe ischemia and can be localized to one of three vascular levels: buttock/thigh claudication to aorto-iliac obstruction, calf claudication to femoral-popliteal artery obstruction, and the less commonly recognized foot/ankle claudication to tibioperoneal artery obstruction. Note that there is a relative predominance of femoral-popliteal and tibioperoneal vascular disease in persons with diabetes with relative sparing of the pedal arteries. Rest pain signals critical ischemia. It occurs in the toes and forefoot where it can be difficult to distinguish from neuropathic pain.

27. (After Pompogelli and Campbell, 2002) Ischemic Rest Pain Unilateral (usually) Continuous; ? hs With dependency Absent DP/PT pulses Neuropathic Pain Bilateral (usually) Wax/wane No change with dependency Variable DP/PT pulses Ischemic rest pain is more likely to be unilateral; it tends to be continuous but increases at night in the supine position with partial relief by dependency; it is associated with the absence of both pedal pulses. In contrast, neuropathic pain is usually bilateral, waxes and wanes without relation to position, and is unrelated to the presence or absence of pedal pulses. Ischemic rest pain is more likely to be unilateral; it tends to be continuous but increases at night in the supine position with partial relief by dependency; it is associated with the absence of both pedal pulses. In contrast, neuropathic pain is usually bilateral, waxes and wanes without relation to position, and is unrelated to the presence or absence of pedal pulses.

28. HX TO DETECT PAD IN DIABETES Asymptomatic, severe PAD common in diabetes Tibio-peroneal disease predominance: Unrecognized ankle/foot claudication No claudication Sensory neuropathy blunts/eliminates pain sensation of claudication and rest pain Diabetes Care 2003; 26:3333 Unfortunately, asymptomatic but severe PAD is common in persons with diabetes, probably for two reasons. First, in patients with advanced tibioperoneal disease ankle and foot claudication may go unrecognized � mistaken as arthritic pain � or may never occur at all. Second, concurrent sensory neuropathy may blunt or even eliminate the pain sensation of claudication and rest pain.Unfortunately, asymptomatic but severe PAD is common in persons with diabetes, probably for two reasons. First, in patients with advanced tibioperoneal disease ankle and foot claudication may go unrecognized � mistaken as arthritic pain � or may never occur at all. Second, concurrent sensory neuropathy may blunt or even eliminate the pain sensation of claudication and rest pain.

29. EXAM TO DETECT PAD IN DIABETES Pedal pulse exam: Absent DP and PT: LR = 3.0-3.8 for severe PAD Absent DP or PT not predict PAD Non-palpable DP (8%) or PT (3%) in normals Present DP and PT not R/O PAD! 30% with PAD have one palpable pulse (collaterals) High PAD suspicion ? vascular testing Claudication, foot ulcer JAMA 2006; 295:536 Arch Intern Med 1998; 158:1357 Diabetes Care 2003; 26:3333 The pedal pulse exam can help to detect PAD in patients with diabetes, but it may also be misleading. The absence of both the dorsalis pedis (DP) and posterior tibial (PT) pulses significantly increases the likelihood of severe PAD (likelihood ratio = 3.0-3.8). In contrast, the absence of just one pedal pulse is not predictive of PAD because the DP and PT pulses are not palpable in 8% and 2% of the normal population, respectively; these pulses can be detected by Doppler flowmeter in most patients as congenital absence of the DP (2%) and PT (0.1%) pulses is uncommon. Unfortunately, the presence of pedal pulses does not rule out severe PAD (Ankle-brachial index below 0.5): 30% of diabetic persons with severe PAD have a palpable PT or DP pulse due to collateral blood flow. Therefore patients with a high suspicion for PAD due to claudication or a foot ulcer should undergo additional vascular testing. The pedal pulse exam can help to detect PAD in patients with diabetes, but it may also be misleading. The absence of both the dorsalis pedis (DP) and posterior tibial (PT) pulses significantly increases the likelihood of severe PAD (likelihood ratio = 3.0-3.8). In contrast, the absence of just one pedal pulse is not predictive of PAD because the DP and PT pulses are not palpable in 8% and 2% of the normal population, respectively; these pulses can be detected by Doppler flowmeter in most patients as congenital absence of the DP (2%) and PT (0.1%) pulses is uncommon. Unfortunately, the presence of pedal pulses does not rule out severe PAD (Ankle-brachial index below 0.5): 30% of diabetic persons with severe PAD have a palpable PT or DP pulse due to collateral blood flow. Therefore patients with a high suspicion for PAD due to claudication or a foot ulcer should undergo additional vascular testing.

30. EXAM TO DETECT PAD IN DIABETES Venous filling time Technique: Sitting: ID pedal vein bulging above skin Supine: Elevate leg to 45� for 1 min Sitting: ? time to pedal vein bulging above skin J Clin Epidemiol 1997; 50:659 Arch Intern Med 1998; 158:1357 Measurement of venous filling time is specific but not sensitive for the detection of PAD. The test is based on the fact that once emptied, pedal veins fill more slowly in persons with PAD. The patient sits on an exam table with feet dangling and a pedal vein bulging above the skin on the dorsum of the foot is identified. The patient is then placed in the supine position, and the leg is elevated to a 45 degree angle for one minute. The patient then sits and dangles the foot while the time is measured until the pedal vein rises to the same height above the skin. Measurement of venous filling time is specific but not sensitive for the detection of PAD. The test is based on the fact that once emptied, pedal veins fill more slowly in persons with PAD. The patient sits on an exam table with feet dangling and a pedal vein bulging above the skin on the dorsum of the foot is identified. The patient is then placed in the supine position, and the leg is elevated to a 45 degree angle for one minute. The patient then sits and dangles the foot while the time is measured until the pedal vein rises to the same height above the skin.

31. EXAM TO DETECT PAD IN DIABETES Venous filling time Filling time > 20 sec predicts ABI < 0.5 Sensitivity = 22%; Specificity = 94%; LR = 3.9 J Clin Epidemiol 1997; 50:659 Arch Intern Med 1998; 158:1357 In one study, a venous filling time over 20 seconds predicted an ABI < 0.5 (severe ischemia) with a sensitivity of 22%, specificity of 94%, and a likelihood ratio of 3.9.In one study, a venous filling time over 20 seconds predicted an ABI < 0.5 (severe ischemia) with a sensitivity of 22%, specificity of 94%, and a likelihood ratio of 3.9.

32. OTHER EXAM FINDINGS FOR PAD Helpful: Femoral bruit (?LR = 4.7�5.7) Unilateral cool extremity Not predictive of PAD: Atrophic skin Hair loss Capillary refill > 5 sec Diabetes Med 2005; 22:1310 Arch Intern Med 1998; 158:1357 The presence of a femoral bruit (positive likelihood ratio = 4.7-5.7) or a unilateral cool extremity also predict PAD. Importantly, the findings of atrophic skin, hair loss, and a capillary refill time greater than 5 seconds are not predictive of PAD.The presence of a femoral bruit (positive likelihood ratio = 4.7-5.7) or a unilateral cool extremity also predict PAD. Importantly, the findings of atrophic skin, hair loss, and a capillary refill time greater than 5 seconds are not predictive of PAD.

33. A much more useful noninvasive test to diagnose PAD in diabetes is the Ankle-Brachial Index (ABI). The (ABI) is performed with a handheld Doppler Flow meter to measure systolic blood pressure in both arms and in the DP and PT arteries. The ABI is calculated by dividing the highest pressure measured at the ankle by the highest brachial pressure. [PATRICK AND TED: DO NOT HAVE PERMISSION TO USE. REFERENCE IS: Norman PE, Eikelboom JW, Hankey GJ. Peripheral arterial disease: prognostic significance and prevention of atherothrombotic complications. Medical Journal of Australia 2004; 181:150-154. Figure 1, p.151A much more useful noninvasive test to diagnose PAD in diabetes is the Ankle-Brachial Index (ABI). The (ABI) is performed with a handheld Doppler Flow meter to measure systolic blood pressure in both arms and in the DP and PT arteries. The ABI is calculated by dividing the highest pressure measured at the ankle by the highest brachial pressure. [PATRICK AND TED: DO NOT HAVE PERMISSION TO USE. REFERENCE IS: Norman PE, Eikelboom JW, Hankey GJ. Peripheral arterial disease: prognostic significance and prevention of atherothrombotic complications. Medical Journal of Australia 2004; 181:150-154. Figure 1, p.151

34. VASCULAR LAB TO DETECT PAD Ankle/Brachial BP Index or ABI Testing Screening: 2004 ADA recommendation �Consider� at age 50 and q 5 yr Screen earlier if multiple CVD risks Diagnosis: Claudication, absent DP/PT pulses, foot ulcer Limitations: Underestimate severity if medial artery Ca++ Consider pulse volume recording, systolic toe BP, vascular consultation if uncertain about PAD Diabetes Care 2005; 28:2206 Diabetes Care 2004; 27(Suppl 1): S15-S35 Given the limitations of history and physical exam, in 2004 the American Diabetes Association recommended that physicians consider screening diabetic patients with an ABI measurement to detect PAD beginning at age 50 with repeat measurements every five years thereafter; screening can begin even earlier if multiple cardiovascular disease risk factors are present. ABI should certainly be performed for diagnosis in diabetic patients with claudication, absence of both pedal pulses, or with a foot ulcer irrespective of other physical exam findings. Unfortunately, ABI measurements may underestimate the severity of PAD in diabetic patients with peripheral neuropathy due to the frequent presence of medial calcification of the artery and poor compressibility. In patients at high risk for PAD because of the presence of claudication or foot ulcer, vascular consultation should be obtained with consideration of additional vascular testing such as qualitative wave form analysis and systolic toe blood pressures. Given the limitations of history and physical exam, in 2004 the American Diabetes Association recommended that physicians consider screening diabetic patients with an ABI measurement to detect PAD beginning at age 50 with repeat measurements every five years thereafter; screening can begin even earlier if multiple cardiovascular disease risk factors are present. ABI should certainly be performed for diagnosis in diabetic patients with claudication, absence of both pedal pulses, or with a foot ulcer irrespective of other physical exam findings. Unfortunately, ABI measurements may underestimate the severity of PAD in diabetic patients with peripheral neuropathy due to the frequent presence of medial calcification of the artery and poor compressibility. In patients at high risk for PAD because of the presence of claudication or foot ulcer, vascular consultation should be obtained with consideration of additional vascular testing such as qualitative wave form analysis and systolic toe blood pressures.

35. INTERPRETATION OF THE ABI ABI Normal 0.91-1.30 Mild obstruction 0.71-0.90 *Moderate obstruction 0.41-0.70 *Severe obstruction ? 0.40 **Poorly compressible >1.30 2� to medial Ca++ *Poor ulcer healing with ABI ? 0.50 **Further vascular evaluation needed A normal ABI is 0.91-1.3. Most patients with claudication have an ABI between 0.4-0.8. An ABI equal to or below 0.4-0.5 is consistent with severe obstruction and a poor prognosis for the healing of a foot ulcer without revascularization. ABI values above 1.3 are usually due to poorly compressible arteries from medial calcification; further vascular evaluation is needed. A normal ABI is 0.91-1.3. Most patients with claudication have an ABI between 0.4-0.8. An ABI equal to or below 0.4-0.5 is consistent with severe obstruction and a poor prognosis for the healing of a foot ulcer without revascularization. ABI values above 1.3 are usually due to poorly compressible arteries from medial calcification; further vascular evaluation is needed.

36. MOTOR NEUROPATHY AND FOOT DEFORMITIES Hammer toes Claw toes Prominent metatarsal heads Hallux valgus Collapsed plantar arch Diabetic motor neuropathy contributes to the development of several important foot deformities including hammer toes, claw toes, prominent metatarsal heads with inadequate plantar soft tissue cushioning, hallux valgus, and a collapsed plantar arch. Because they are common and lead to areas of especially high pressure over bony prominences, claw toes and prominent metatarsal heads are probably the most important deformities.Diabetic motor neuropathy contributes to the development of several important foot deformities including hammer toes, claw toes, prominent metatarsal heads with inadequate plantar soft tissue cushioning, hallux valgus, and a collapsed plantar arch. Because they are common and lead to areas of especially high pressure over bony prominences, claw toes and prominent metatarsal heads are probably the most important deformities.

37. Diabetic motor neuropathy leads to atrophy of the intrinsic musculature of the foot with consequent dorsiflexion of the proximal phalanx to form a hammer toe. Dorsiflexion of the middle phalanx and a flexion contracture of the distal phalanx convert the hammer toe into a claw toe. Note the increasingly prominent metatarsal heads with these two deformities. These deformities result in areas of high pressure and subsequent callus formation over the metatarsal head and the tip of the toe when walking, and over the distal end of the proximal phalanx from shoe gear. [PATRICK AND TED: I DO NOT HAVE PERMISSION TO USE THIS DIAGRAM IN A MONOGRAPH THAT IS FOR SALE, AND I DOUBT IT WILL BE GRANTED BY THE AMERICAN DIABETES ASSOCIATION. DO YOU HAVE ARTISTS TO DRAW A SIMILAR PICTURE?]Diabetic motor neuropathy leads to atrophy of the intrinsic musculature of the foot with consequent dorsiflexion of the proximal phalanx to form a hammer toe. Dorsiflexion of the middle phalanx and a flexion contracture of the distal phalanx convert the hammer toe into a claw toe. Note the increasingly prominent metatarsal heads with these two deformities. These deformities result in areas of high pressure and subsequent callus formation over the metatarsal head and the tip of the toe when walking, and over the distal end of the proximal phalanx from shoe gear. [PATRICK AND TED: I DO NOT HAVE PERMISSION TO USE THIS DIAGRAM IN A MONOGRAPH THAT IS FOR SALE, AND I DOUBT IT WILL BE GRANTED BY THE AMERICAN DIABETES ASSOCIATION. DO YOU HAVE ARTISTS TO DRAW A SIMILAR PICTURE?]

38. Hallux valgus deformities are more common in persons with diabetes and result in high pressure points from shoe gear at the distal end of the proximal phalanx. [PATRICK AND TED: FROM SAME REFERENCE, NO PERMISSION]Hallux valgus deformities are more common in persons with diabetes and result in high pressure points from shoe gear at the distal end of the proximal phalanx. [PATRICK AND TED: FROM SAME REFERENCE, NO PERMISSION]

39. The pes cavus deformity � a �high� plantar arch � leads to areas of high pressure over the heel, the metatarsal heads, and the plantar surface of the toes. The pes planus or midfoot collapse deformity resulting from a Charcot foot creates an area of high pressure on the plantar surface of the midfoot. All of the shaded areas on the foot deformities in this diagram are at risk for callus formation and subsequent ulceration. [PATRICK AND TED: I DO NOT HAVE PERMISSION TO REPRODUCE THIS]The pes cavus deformity � a �high� plantar arch � leads to areas of high pressure over the heel, the metatarsal heads, and the plantar surface of the toes. The pes planus or midfoot collapse deformity resulting from a Charcot foot creates an area of high pressure on the plantar surface of the midfoot. All of the shaded areas on the foot deformities in this diagram are at risk for callus formation and subsequent ulceration. [PATRICK AND TED: I DO NOT HAVE PERMISSION TO REPRODUCE THIS]

40. PRE-ULCER CUTANEOUS PATHOLOGY Neuropathy ? inappropriate footwear: Persistent erythema after shoe removal Callus Callus with subcutaneous hemorrhage: �pre-ulcer� Autonomic neuropathy and secondary dry skin: Fissure ? ulceration Augment callus formation Poor self-care of the feet: Interdigital maceration with fungal infection Nail pathology In addition to major foot deformities it is also essential for clinicians to recognize pre-ulcerative cutaneous pathology. Combinations of sensory, motor, and autonomic neuropathy and inappropriate footwear can lead to several cutaneous lesions. The earliest abnormality is an area of persistent erythema following removal of the shoe indicating excessive pressure at the site. Without intervention, callus and later callus with subcutaneous hemorrhage � the �pre-ulcer� � may develop. Autonomic neuropathy and consequent reduced sweating leads to excessively dry skin on the feet. Dry skin augments callus formation and can also fissure and progress to frank ulceration. Poor self-foot care behaviors can lead to fungal infection and subsequent interdigital maceration along with several types of nail pathology that can progress to foot ulceration.In addition to major foot deformities it is also essential for clinicians to recognize pre-ulcerative cutaneous pathology. Combinations of sensory, motor, and autonomic neuropathy and inappropriate footwear can lead to several cutaneous lesions. The earliest abnormality is an area of persistent erythema following removal of the shoe indicating excessive pressure at the site. Without intervention, callus and later callus with subcutaneous hemorrhage � the �pre-ulcer� � may develop. Autonomic neuropathy and consequent reduced sweating leads to excessively dry skin on the feet. Dry skin augments callus formation and can also fissure and progress to frank ulceration. Poor self-foot care behaviors can lead to fungal infection and subsequent interdigital maceration along with several types of nail pathology that can progress to foot ulceration.

41. Areas of erythema that persist after removal of the shoe are an indication of excessive pressure from inappropriately fitted shoe gear. Over time, these areas of erythema are sites for callus and ulcer formation. Also note the excessively dry skin. Areas of erythema that persist after removal of the shoe are an indication of excessive pressure from inappropriately fitted shoe gear. Over time, these areas of erythema are sites for callus and ulcer formation. Also note the excessively dry skin.

42. This patient has a marked Hallux valgus deformity and early hammer-toe deformities from diabetic motor neuropathy. Note the areas of persistent erythema over pressure points on the first MTP joint and on the dorsums of the proximal phalanges. This patient requires a modification of shoe gear to relieve pressure and prevent callus and ulcer formation. This patient has a marked Hallux valgus deformity and early hammer-toe deformities from diabetic motor neuropathy. Note the areas of persistent erythema over pressure points on the first MTP joint and on the dorsums of the proximal phalanges. This patient requires a modification of shoe gear to relieve pressure and prevent callus and ulcer formation.

43. In this patient with early hammer and claw-toe deformities there are areas of persistent erythema on the dorsum of the proximal phalanges caused by excessive pressure from poorly-fitted shoe gear. In this patient with early hammer and claw-toe deformities there are areas of persistent erythema on the dorsum of the proximal phalanges caused by excessive pressure from poorly-fitted shoe gear.

44. This patient has much more severe hammer and claw-toe deformities. There are areas of persistent erythema on the dorsum of the fourth and fifth toes. However, the consequences of the ill-fitting shoe gear have now progressed to marked callus formation at the peak of the hammer toe deformities on the dorsum of the second and third toes. This patient has much more severe hammer and claw-toe deformities. There are areas of persistent erythema on the dorsum of the fourth and fifth toes. However, the consequences of the ill-fitting shoe gear have now progressed to marked callus formation at the peak of the hammer toe deformities on the dorsum of the second and third toes.

45. This patient has significant hammer and claw-toe deformities. The claw-toes have resulted in the build-up of significant callus on the tips of the toes. Unless the patient�s shoe gear is modified, these calluses are at high risk to ulcerate in the future.This patient has significant hammer and claw-toe deformities. The claw-toes have resulted in the build-up of significant callus on the tips of the toes. Unless the patient�s shoe gear is modified, these calluses are at high risk to ulcerate in the future.

46. In this patient diabetic motor neuropathy has resulted in hammer and claw-toe deformities and very prominent metatarsal heads on the plantar surface of the foot. Excessive pressure on the metatarsal heads and inadequate shoe gear have resulted in marked callus build-up that is further accelerated by the dry skin. The patient is at high risk for ulceration at these sites. In this patient diabetic motor neuropathy has resulted in hammer and claw-toe deformities and very prominent metatarsal heads on the plantar surface of the foot. Excessive pressure on the metatarsal heads and inadequate shoe gear have resulted in marked callus build-up that is further accelerated by the dry skin. The patient is at high risk for ulceration at these sites.

47. This patient has a pes cavus or high plantar arch deformity that has resulted in pressure points and callus formation over the heels, metatarsal heads, and along the medial aspect of the great toe. Extensive callus increases the subcutaneous pressure immediately beneath the callus and can result in a subcutaneous hemorrhage, the so-called �pre-ulcer.� Note also this patient�s extensive nail pathology.This patient has a pes cavus or high plantar arch deformity that has resulted in pressure points and callus formation over the heels, metatarsal heads, and along the medial aspect of the great toe. Extensive callus increases the subcutaneous pressure immediately beneath the callus and can result in a subcutaneous hemorrhage, the so-called �pre-ulcer.� Note also this patient�s extensive nail pathology.

48. This is an example of a pre-ulcer, a callus beneath which is a subcutaneous hemorrhage as indicated by the visible hemosiderin deposits. With continued pressure this pre-ulcer is likely to progress to a frank ulcer. Prompt referral to podiatry is indicated. This is an example of a pre-ulcer, a callus beneath which is a subcutaneous hemorrhage as indicated by the visible hemosiderin deposits. With continued pressure this pre-ulcer is likely to progress to a frank ulcer. Prompt referral to podiatry is indicated.

49. Without very careful physical examination of the feet, this pre-ulcer (callus with subcutaneous hemorrhage) on the tip of the third digit with its claw-toe deformity could easily go undetected. Pre-ulcers must be promptly and carefully debrided to determine if there is already an underlying ulcer. Without very careful physical examination of the feet, this pre-ulcer (callus with subcutaneous hemorrhage) on the tip of the third digit with its claw-toe deformity could easily go undetected. Pre-ulcers must be promptly and carefully debrided to determine if there is already an underlying ulcer.

50. Fortunately, in this patient debridement did not reveal an underlying ulcer. Debridement of callus reduces subcutaneous pressure and helps to prevent subcutaneous hemorrhage and progression to an ulcer. This patient�s socks and shoe gear will have to be modified to accommodate his claw-toe deformities. Fortunately, in this patient debridement did not reveal an underlying ulcer. Debridement of callus reduces subcutaneous pressure and helps to prevent subcutaneous hemorrhage and progression to an ulcer. This patient�s socks and shoe gear will have to be modified to accommodate his claw-toe deformities.

51. Here is a less fortunate patient with a claw-toe deformity and a now debrided pre-ulcer at the tip of the third toe. An early ulceration is already apparent that will require local wound care and off-loading of pressure in order to heal. Here is a less fortunate patient with a claw-toe deformity and a now debrided pre-ulcer at the tip of the third toe. An early ulceration is already apparent that will require local wound care and off-loading of pressure in order to heal.

52. Diabetic autonomic neuropathy leads to decreased sweating, very dry skin, and consequent fissure formation, as noted in this patient on the plantar surface of the first metatarsal head. Without careful physical examination such fissures easily go undetected; some will become secondarily infected and ulcerate. Diabetic autonomic neuropathy leads to decreased sweating, very dry skin, and consequent fissure formation, as noted in this patient on the plantar surface of the first metatarsal head. Without careful physical examination such fissures easily go undetected; some will become secondarily infected and ulcerate.

53. Perhaps 50% or more of patients with diabetes are unable to reach their feet because of obesity or are unable to see their feet due to retinopathy. Severe nail abnormalities can result. Torsion of the excessively long nail on the great toe could lead to trauma to the nail bed, secondary infection, and ulceration. The nail curving over the top of the second toe has the potential to lacerate the plantar surface of the toe. Because of sensory neuropathy the patient may be unaware of any discomfort. Perhaps 50% or more of patients with diabetes are unable to reach their feet because of obesity or are unable to see their feet due to retinopathy. Severe nail abnormalities can result. Torsion of the excessively long nail on the great toe could lead to trauma to the nail bed, secondary infection, and ulceration. The nail curving over the top of the second toe has the potential to lacerate the plantar surface of the toe. Because of sensory neuropathy the patient may be unaware of any discomfort.

54. These nails are grossly hypertrophied from fungal infection in this patient with no prior access to podiatric care. Due to the increased pressure transmitted to underlying tissues, these nails can damage the nail bed which may then become secondarily infected and ulcerate. These nails are grossly hypertrophied from fungal infection in this patient with no prior access to podiatric care. Due to the increased pressure transmitted to underlying tissues, these nails can damage the nail bed which may then become secondarily infected and ulcerate.

55. It is essential to carefully examine the interdigital spaces between the toes to detect maceration that results from excessive moisture and concurrent fungal infection as these lesions can progress to ulceration. However, in this patient a pre-ulcer was discovered instead, the result of excessive pressure from an adjacent deformed toe rubbing against it. It is essential to carefully examine the interdigital spaces between the toes to detect maceration that results from excessive moisture and concurrent fungal infection as these lesions can progress to ulceration. However, in this patient a pre-ulcer was discovered instead, the result of excessive pressure from an adjacent deformed toe rubbing against it.

56. This diabetic patient has multiple abnormalities: hammer and claw-toe deformities, callus formation, nail pathology, and very dry skin with early fissure formation.This diabetic patient has multiple abnormalities: hammer and claw-toe deformities, callus formation, nail pathology, and very dry skin with early fissure formation.

57. RISK-STRATIFIED FOOTCARE MANAGEMENT FOR DIABETES PATIENTS Let�s now review a risk-stratified approach to foot care management for patients with diabetesLet�s now review a risk-stratified approach to foot care management for patients with diabetes

58. LOW RISK: CATEGORY 0 PATIENTS Annual comprehensive foot examination Questionnaire completed by patient in waiting room Examination form with decision-support (See Tool-Kit) Every visit visual inspection if higher risk Racial/ethnic minorities; alcoholism; homeless Basic education: self-management, appropriate footwear Brief counseling Written handout JAMA 2005; 293:217 Low risk, Category 0 patients have intact protective sensation to the 10-gram monofilament, no major foot deformities, pedal pulses are present, and there is no prior history of foot ulcer or amputation. Category 0 patients require an annual comprehensive foot examination as described previously. This examination can be facilitated by a questionnaire that patients complete in the waiting room and a decision-supported diabetic foot examination form (SEE TOOL-KIT). Category 0 patients at higher risk of foot ulcer-persons from racial minority groups or persons who are homeless or suffer from alcoholism � should additionally have a visual inspection of their feet at every visit. Category 0 patients should have basic foot care education about self-management of their feet and appropriate footwear. This can be accomplished with brief counseling and a short, written patient education handout (SEE TOOL-KIT).Low risk, Category 0 patients have intact protective sensation to the 10-gram monofilament, no major foot deformities, pedal pulses are present, and there is no prior history of foot ulcer or amputation. Category 0 patients require an annual comprehensive foot examination as described previously. This examination can be facilitated by a questionnaire that patients complete in the waiting room and a decision-supported diabetic foot examination form (SEE TOOL-KIT). Category 0 patients at higher risk of foot ulcer-persons from racial minority groups or persons who are homeless or suffer from alcoholism � should additionally have a visual inspection of their feet at every visit. Category 0 patients should have basic foot care education about self-management of their feet and appropriate footwear. This can be accomplished with brief counseling and a short, written patient education handout (SEE TOOL-KIT).

59. HIGH RISK: CATEGORY 1-3 PATIENTS Annual comprehensive foot exam Inspect feet at every office visit Podiatry care stratified to risk level Intensive patient education Detect/manage barriers to foot care Therapeutic footwear, if needed High risk category 1-3 patients, who have sensory neuropathy and one or more of the other key risk factors of major skeletal deformity, peripheral arterial disease, and/or prior foot ulcer or amputation, require a more aggressive approach to prevention. In addition to an annual comprehensive foot examination, the feet should be carefully inspected at every office visit, and patients should be referred to podiatry at a frequency stratified according to their risk level. Intensive patient education is essential, and any barriers preventing optimal foot care should be detected and managed. Finally, select patients may benefit from the use of therapeutic footwear. High risk category 1-3 patients, who have sensory neuropathy and one or more of the other key risk factors of major skeletal deformity, peripheral arterial disease, and/or prior foot ulcer or amputation, require a more aggressive approach to prevention. In addition to an annual comprehensive foot examination, the feet should be carefully inspected at every office visit, and patients should be referred to podiatry at a frequency stratified according to their risk level. Intensive patient education is essential, and any barriers preventing optimal foot care should be detected and managed. Finally, select patients may benefit from the use of therapeutic footwear.

60. HIGH RISK: CATEGORY 1-3 PATIENTS Nursing tasks to facilitate foot exams: �High Risk Feet� stickers to each chart (Tool-Kit) Remove patient�s shoes/socks Increases % of foot exams in observational studies Determine that patient can reach/see soles of feet Stock 10g monofilament in each room Consider training to perform 10g monofilament exam Provide patient education forms Literacy/language appropriate Diabetes Care 1983; 6:499 J Gen Intern Med 2003; 18:258 Nurses and medical assistants can facilitate the performance of foot examinations in the office setting, first by identifying high risk patients with a chart sticker (SEE TOOL-KIT). They can remove the patient�s shoes and socks prior to the clinician entering the room; in observational studies this simple maneuver was shown to significantly increase the number of foot exams performed on diabetic patients. They should determine that the patient can both reach and see the soles of their feet. They should keep each exam room well-stocked with 10-gram monofilaments, and it may be reasonable to train them to accurately perform the monofilament examination. Finally, they should provide the patient with written education materials appropriate to their level of literacy and language needs. Nurses and medical assistants can facilitate the performance of foot examinations in the office setting, first by identifying high risk patients with a chart sticker (SEE TOOL-KIT). They can remove the patient�s shoes and socks prior to the clinician entering the room; in observational studies this simple maneuver was shown to significantly increase the number of foot exams performed on diabetic patients. They should determine that the patient can both reach and see the soles of their feet. They should keep each exam room well-stocked with 10-gram monofilaments, and it may be reasonable to train them to accurately perform the monofilament examination. Finally, they should provide the patient with written education materials appropriate to their level of literacy and language needs.

61. This slide shows an example of the �High Risk Feet� chart sticker to attach to the charts of category 1-3 patients (SEE TOOL-KIT).This slide shows an example of the �High Risk Feet� chart sticker to attach to the charts of category 1-3 patients (SEE TOOL-KIT).

62. This slide shows a sample of an exam room poster reminding nursing staff and diabetes patients to remove their shoes and socks to facilitate foot examinations (SEE TOOL-KIT).This slide shows a sample of an exam room poster reminding nursing staff and diabetes patients to remove their shoes and socks to facilitate foot examinations (SEE TOOL-KIT).

63. HIGH RISK: CATEGORY 1-3 PATIENTS Regular prophylactic podiatry care: Provide nail and skin care Assess footwear needs RCT: 48% RRR for recurrent ulceration Optimal visit frequency not evidence-based: Category 1 ? q 3-6 mo Category 2 ? q 2-3 mo Category 3 ? q 1-2 mo Diabetes Care 2003; 26:1691 J Fam Practice 2000; 49(Suppl):S30 High risk category 1-3 patients should be referred to podiatry for regular prophylactic care of their skin and nails and for assessment of their footwear needs. A randomized clinical trial demonstrated a 48% relative risk reduction for recurrent foot ulceration in patients who had regular podiatric care. The optimal frequency of visits to podiatry has not been determined. Some investigators suggest that category 1 patients be seen every 3-6 months while category 2 and especially category 3 patients be seen more frequently.High risk category 1-3 patients should be referred to podiatry for regular prophylactic care of their skin and nails and for assessment of their footwear needs. A randomized clinical trial demonstrated a 48% relative risk reduction for recurrent foot ulceration in patients who had regular podiatric care. The optimal frequency of visits to podiatry has not been determined. Some investigators suggest that category 1 patients be seen every 3-6 months while category 2 and especially category 3 patients be seen more frequently.

64. HIGH RISK: CATEGORY 1-3 PATIENTS Intensive patient education: 1? care clinician, podiatrist, educator contribute Reinforce frequently � low retention documented Patient to demonstrate self-care knowledge Questionnaires, tests are available (see Tool-Kit) Utility: ? Reduced foot ulcer/amputation rates? Cochrane Database Syst Rev 2005 Jan 25;(1)CD001488 Foot Ankle Int 2005; 26:38 High risk category 1-3 patients should receive intensive education from primary care clinicians, podiatrists, and diabetes educators. This education should be reinforced frequently as clinical studies have demonstrated low retention of this information. In particular, patients should be asked to demonstrate their self-care knowledge, and this can be efficiently accomplished using available questionnaires (SEE TOOL-KIT). A systematic overview of clinical trials suggests that patient education may reduce the rate of foot ulcer and amputation although the quality of available studies is low. High risk category 1-3 patients should receive intensive education from primary care clinicians, podiatrists, and diabetes educators. This education should be reinforced frequently as clinical studies have demonstrated low retention of this information. In particular, patients should be asked to demonstrate their self-care knowledge, and this can be efficiently accomplished using available questionnaires (SEE TOOL-KIT). A systematic overview of clinical trials suggests that patient education may reduce the rate of foot ulcer and amputation although the quality of available studies is low.

65. BASIC FOOT CARE CONCEPTS Daily foot inspection May require mirror, magnification, or caregiver Educate patient to recognize/report ASAP: Persistent erythema Enlarging callus Pre-ulcer (callus with hemorrhage) A central concept of basic foot care is daily inspection of the feet. This may require use of a mirror by patients who cannot reach their feet or a magnification glass by patients who cannot see their feet. In some patients the exam may need to be done by a caregiver. Patients should be educated to recognize important foot lesions and report them immediately including areas of persistent erythema following shoe removal, enlarging callus, and pre-ulcers (callus with hemorrhage).A central concept of basic foot care is daily inspection of the feet. This may require use of a mirror by patients who cannot reach their feet or a magnification glass by patients who cannot see their feet. In some patients the exam may need to be done by a caregiver. Patients should be educated to recognize important foot lesions and report them immediately including areas of persistent erythema following shoe removal, enlarging callus, and pre-ulcers (callus with hemorrhage).

66. BASIC FOOT CARE CONCEPTS Commitment to self-care: Wash/dry daily Avoid hot water; dry thoroughly between toes Lubricate daily (not between toes) Debride callus/corn to reduce plantar pressure 25% Avoid sharp instruments, corn plasters No self-cutting of nails if: Neuropathy, PAD, poor vision Diabetic patients must make a commitment to self-care of the feet including daily cleansing with care to avoid excessively hot water and to dry thoroughly between the toes. The feet should be lubricated daily but not between the toes, a site for excessive moisture and maceration. Debridement of callus with a pumice stone may reduce plantar pressure by 25%, but debridement should not be accomplished with sharp instruments like razor blades or over-the-counter corn plasters that can cause a chemical burn. Patients should not cut their own nails if they have significant sensory neuropathy, peripheral arterial disease, or poor vision. Diabetic patients must make a commitment to self-care of the feet including daily cleansing with care to avoid excessively hot water and to dry thoroughly between the toes. The feet should be lubricated daily but not between the toes, a site for excessive moisture and maceration. Debridement of callus with a pumice stone may reduce plantar pressure by 25%, but debridement should not be accomplished with sharp instruments like razor blades or over-the-counter corn plasters that can cause a chemical burn. Patients should not cut their own nails if they have significant sensory neuropathy, peripheral arterial disease, or poor vision.

67. BASIC FOOT CARE CONCEPTS Protective behaviors: Avoid temperature extremes No walking barefoot/stocking-footed Appropriate exercise if sensory neuropathy Bicycle/swim > walking/treadmill Inspect shoes for foreign objects Optimal footwear at all times Patient foot care education should include cautions to avoid temperature extremes (walking barefoot in hot water or on hot sand, pavement or in snow) as well as to never walk barefoot or stocking-footed, a source of many traumatic injuries. Appropriate exercise is important for patients with diabetes, but patients with significant sensory neuropathy and loss of protective sensation may be better served by bicycling or swimming than by walking or treadmill exercise. Patients with significant neuropathy should inspect their shoes for foreign objects before they put them on. Optimal footwear is effective only if it is worn at all times; dangerous blisters may form when inappropriate footwear is used for special occasions. Patient foot care education should include cautions to avoid temperature extremes (walking barefoot in hot water or on hot sand, pavement or in snow) as well as to never walk barefoot or stocking-footed, a source of many traumatic injuries. Appropriate exercise is important for patients with diabetes, but patients with significant sensory neuropathy and loss of protective sensation may be better served by bicycling or swimming than by walking or treadmill exercise. Patients with significant neuropathy should inspect their shoes for foreign objects before they put them on. Optimal footwear is effective only if it is worn at all times; dangerous blisters may form when inappropriate footwear is used for special occasions.

68. FOOT CARE EDUCATION TOOLS �Prevent diabetes problems: Keep your feet and skin healthy� Cartoons � minimal text � still simple www.niddk.nih.gov or ndic@info.niddk.nih.gov �Take Care of Your Feet For a Lifetime� � booklet Few cartoons � more advanced http://ndep.nih.gov/materials/pubs/feet/brochure/index.htm �Take Care of Your Feet For a Lifetime� � 1 page summary www.ndep.nih.gov/diabetes/pubs/FootTips.pdf Excellent foot care education tools are available from the federal government at the websites listed on this slide. They range from simple cartoons with minimal text for patients with low levels of literacy to more sophisticated tools. The last tool on the slide, �Take Care of Your Feet For A Lifetime�, is a 1 page summary useful for lower risk, category 0 patients.Excellent foot care education tools are available from the federal government at the websites listed on this slide. They range from simple cartoons with minimal text for patients with low levels of literacy to more sophisticated tools. The last tool on the slide, �Take Care of Your Feet For A Lifetime�, is a 1 page summary useful for lower risk, category 0 patients.

69. FOOT CARE EDUCATION TOOLS �Diabetic Foot Care� American Orthopedic Foot and Ankle Society Multilingual translation Available in 20 languages Reference: Trepman E, et al. Foot and Ankle International 2005; 26:64-107. Recently, the American Orthopedic Foot and Ankle Society produced a foot care education tool that they have translated into 20 languages. The tool is available in the 2005 journal article referenced in the slide. Recently, the American Orthopedic Foot and Ankle Society produced a foot care education tool that they have translated into 20 languages. The tool is available in the 2005 journal article referenced in the slide.

70. EDUCATIONAL DEFICIENCIES: HIGH RISK PATIENTS How serious are patient educational deficiencies for diabetic foot care? The answer is very serious. Reiber questioned 558 high risk patients about their foot care practices. Fifty percent did not inspect their feet regularly, 62% regularly walked barefoot or in stockings, 40% seldom or never tested the temperature of bath water, 48% trimmed callus with sharp instruments, 58% did not consider foot ulcer to be an emergency, and 57% were unsure how to select appropriate footwear. [PATRICK AND TED: THIS INFORMATION IS FROM A LECTURE BY DR GAYLE REIBER OF THE UNIVERSITY OF WASHINGTON. ACCORDING TO PUB-MED, IT IS AS YET UNPUBLISHED]How serious are patient educational deficiencies for diabetic foot care? The answer is very serious. Reiber questioned 558 high risk patients about their foot care practices. Fifty percent did not inspect their feet regularly, 62% regularly walked barefoot or in stockings, 40% seldom or never tested the temperature of bath water, 48% trimmed callus with sharp instruments, 58% did not consider foot ulcer to be an emergency, and 57% were unsure how to select appropriate footwear. [PATRICK AND TED: THIS INFORMATION IS FROM A LECTURE BY DR GAYLE REIBER OF THE UNIVERSITY OF WASHINGTON. ACCORDING TO PUB-MED, IT IS AS YET UNPUBLISHED]

71. BASIC FOOTWEAR EDUCATION Avoid: Pointed-toes Slip-ons Open-toes High heels Plastic Black color Too small Favor: Broad-round toes Adjustable (laces, buckles, Velcro) Athletic shoes, walking shoes Leather, canvas White/light colors �� between longest toe and end of shoe With respect to basic footwear education, shoes with broad-round toes are favored over shoes with pointed toes to reduce pressure on the lateral edges of the foot. Shoes with adjustable laces, buckles, or Velcro can compensate for end-of-day foot swelling as compared to slip-ons. Athletic or walking shoes are favored over shoes with open toes or high heels, the latter resulting in high plantar pressure on the forefoot. Leather or canvas shoes with white or light colors result in less heat and sweating than plastic shoes, especially if their color is black. Patients should purchase their shoes at the end of the day when swelling is greatest and allow one-half inch between the longest toe and the end of the shoe. An excellent, highly readable patient education handout is available in the reference listed on the slide. With respect to basic footwear education, shoes with broad-round toes are favored over shoes with pointed toes to reduce pressure on the lateral edges of the foot. Shoes with adjustable laces, buckles, or Velcro can compensate for end-of-day foot swelling as compared to slip-ons. Athletic or walking shoes are favored over shoes with open toes or high heels, the latter resulting in high plantar pressure on the forefoot. Leather or canvas shoes with white or light colors result in less heat and sweating than plastic shoes, especially if their color is black. Patients should purchase their shoes at the end of the day when swelling is greatest and allow one-half inch between the longest toe and the end of the shoe. An excellent, highly readable patient education handout is available in the reference listed on the slide.

72. THERAPEUTIC FOOTWEAR: GOALS Inappropriate footwear: Contributes to 21-76% of ulcers/amputations Optimal footwear should: Protect feet from external injury Reduce plantar pressure, shock and shear forces Accommodate, stabilize, support deformities Suitable for occupation, home, leisure Diabetes Care 2004; 27:1832 Diab Metab Res Rev 2004; 20(Suppl1):S51 Therapeutic footwear may benefit selected diabetic patients. Inappropriate footwear is estimated to contribute to 21-76% of foot ulcers and subsequent lower extremity amputations. Optimal footwear should meet several criteria: (1) Protect the feet from external injury (2) Reduce plantar pressure and the shock and shear forces that contribute to callus and ulcer formation (3) Accommodate, stabilize, and support any skeletal deformities of the foot, and (4) Be suitable for use in occupational, home, and leisure settings.Therapeutic footwear may benefit selected diabetic patients. Inappropriate footwear is estimated to contribute to 21-76% of foot ulcers and subsequent lower extremity amputations. Optimal footwear should meet several criteria: (1) Protect the feet from external injury (2) Reduce plantar pressure and the shock and shear forces that contribute to callus and ulcer formation (3) Accommodate, stabilize, and support any skeletal deformities of the foot, and (4) Be suitable for use in occupational, home, and leisure settings.

73. THERAPEUTIC FOOTWEAR: COMPONENTS Padded socks (eg. CoolMax, Duraspun, others) Cushion metatarsal heads, heels, and decrease plantar pressure White, seamless, absorbent acrylic fibers Shoe inserts/insoles (closed-cell foam, viscoelastic) Off-the-shelf Custom-molded Therapeutic shoes Extra-depth ? extra-width Rigid rocker outsoles Custom-molded Padded socks are one component of therapeutic footwear, and several brands are available. Their role is to cushion the metatarsal heads and heels and reduce callus formation. Ideally, the socks should be white to facilitate detection of blood or pus from unrecognized foot ulcer, seamless to minimize pressure points, and absorbent to reduce excessive moisture. Shoe inserts and insoles are designed to reduce plantar pressure. Composed of closed-cell foam or viscoelastic materials, they can be purchased off-the-shelf for some patients, but they may have to be custom-molded for others. Therapeutic shoes can be purchased off-the-shelf with extra-depth to accommodate insoles and/or skeletal deformities, and/or with extra-width for skeletal deformities. Rigid-rocker outsoles can be added to reduce mid-foot pressure. Some patients will require custom-molded shoes. Padded socks are one component of therapeutic footwear, and several brands are available. Their role is to cushion the metatarsal heads and heels and reduce callus formation. Ideally, the socks should be white to facilitate detection of blood or pus from unrecognized foot ulcer, seamless to minimize pressure points, and absorbent to reduce excessive moisture. Shoe inserts and insoles are designed to reduce plantar pressure. Composed of closed-cell foam or viscoelastic materials, they can be purchased off-the-shelf for some patients, but they may have to be custom-molded for others.

74. FOOTWEAR RECOMMENDATIONS BY RISK LEVEL Low Risk (0) Proper style/fit, cushioned stock shoes Sensation (1) Deep toe box shoes, cushioned insoles Callosities, ulcer Hx Extra-depth stock shoes, custom-molded insole Severe deformities Custom-molded extra-depth shoes and insoles, rigid rocker outsoles Modified from The Foot in Diabetes, 2000, p.136 In general, low risk category 0 patients can purchase cushioned stock shoes off-the-shelf according to the proper style and fit discussed earlier. High risk category 1 patients require cushioned insoles and an extra-depth, deep toe box shoe to accommodate the insoles. Patients with extensive callus formation or prior ulceration may require a custom-molded insole along with extra-depth stock shoes to accommodate the insole. Patients with severe skeletal deformities of the feet may require custom-molded insoles and shoes along with rigid rocker outsoles. In general, low risk category 0 patients can purchase cushioned stock shoes off-the-shelf according to the proper style and fit discussed earlier. High risk category 1 patients require cushioned insoles and an extra-depth, deep toe box shoe to accommodate the insoles. Patients with extensive callus formation or prior ulceration may require a custom-molded insole along with extra-depth stock shoes to accommodate the insole. Patients with severe skeletal deformities of the feet may require custom-molded insoles and shoes along with rigid rocker outsoles.

75. THERAPEUTIC FOOTWEAR: EFFICACY Decreases plantar pressure 50-70% Uncertain reduction in ulcer rate: 1? prevention: no data 2? prevention: controversial reduction of ulcer recurrence Analytic/descriptive studies decreases ulcers 50-75% 2 RCTs no benefit Benefits vary with footwear use, risk level? Severe foot deformity, prior toe/ray amputation? Diabetes Care 2004; 27:1774 The efficacy of therapeutic footwear is controversial. While therapeutic footwear clearly reduces plantar pressure 50-70%, its ability to reduce ulcer rates is less well established. No data are available concerning primary prevention of foot ulcer. For secondary prevention, analytic and descriptive studies have found 50-70% reductions in ulcer rates with therapeutic footwear. However, two small randomized clinical trials have demonstrated no benefit. It is likely that benefits are greatest in patients with severe foot deformities or prior amputations who wear their therapeutic footwear consistently. The efficacy of therapeutic footwear is controversial. While therapeutic footwear clearly reduces plantar pressure 50-70%, its ability to reduce ulcer rates is less well established. No data are available concerning primary prevention of foot ulcer. For secondary prevention, analytic and descriptive studies have found 50-70% reductions in ulcer rates with therapeutic footwear. However, two small randomized clinical trials have demonstrated no benefit. It is likely that benefits are greatest in patients with severe foot deformities or prior amputations who wear their therapeutic footwear consistently.

76. MEDICARE COVERAGE OF THERAPEUTIC FOOTWEAR Certify diabetic patient with foot-at-risk 1� care physician Prescribe therapeutic footwear D.P.M., D.O., M.D. Prepare/fit therapeutic footwear Pedorthist, orthotist, prosthetist, D.P.M. www.cpeds.org Foot Ankle Int 2005; 26:42 Medicare will cover much of the cost of therapeutic footwear if primary care physicians will certify that the patient has a foot-at-risk according to set criteria. Therapeutic footwear can then be prescribed by expert podiatrists, osteopaths, or M.D.�s, and the shoes can be prepared and fitted by any of several professionals. Certified pedorthists can be accessed at the website listed on the slide. Medicare will cover much of the cost of therapeutic footwear if primary care physicians will certify that the patient has a foot-at-risk according to set criteria. Therapeutic footwear can then be prescribed by expert podiatrists, osteopaths, or M.D.�s, and the shoes can be prepared and fitted by any of several professionals. Certified pedorthists can be accessed at the website listed on the slide.

77. This slide shows the Medicare form to certify patients for therapeutic footwear. Primary care physicians complete the top half of the form, and the prescribing physician completes the bottom half. (SEE TOOL-KIT)This slide shows the Medicare form to certify patients for therapeutic footwear. Primary care physicians complete the top half of the form, and the prescribing physician completes the bottom half. (SEE TOOL-KIT)

78. MEDICARE COVERAGE OF THERAPEUTIC FOOTWEAR Medicare pays 80% of payment amount allowed: Total Amount Amount Covered by Allowed Medicare Extra Depth shoes $132.00 $105.60Custom-made shoes $396.00 $316.00 Diabetic Pre-fab Insoles $67.00 $53.60 Diabetic Custom Insoles $67.00 $53.60 1 pair extra-depth shoes ? 3 pair insoles/y, or 1 pair extra-depth shoes with modification ? 2 pair insoles/y, or 1 pair custom-molded shoes ? 2 pair insoles/y Medicare will pay 80% of the payment amount allowed as listed on this slide and will provide the type of shoes and number of inserts as listed.Medicare will pay 80% of the payment amount allowed as listed on this slide and will provide the type of shoes and number of inserts as listed.

79. This patient has multiple deformities including hammer and claw toes, prominent metatarsal heads on the plantar surface of the foot and an adductovarus deformity of the fourth toe (the toe literally curves around itself). The patient will require insoles to reduce plantar pressure and an extra-depth shoe with a deep toe box to accommodate the skeletal deformities.This patient has multiple deformities including hammer and claw toes, prominent metatarsal heads on the plantar surface of the foot and an adductovarus deformity of the fourth toe (the toe literally curves around itself). The patient will require insoles to reduce plantar pressure and an extra-depth shoe with a deep toe box to accommodate the skeletal deformities.

80. An extra-depth shoe with a deep toe box with an off-the shelf insoleAn extra-depth shoe with a deep toe box with an off-the shelf insole

81. This patient has a Charcot deformity with extensive collapse of the skeletal architecture of the foot. Note that a toe is missing from a prior amputation. Deformities of this magnitude require custom-made insoles to reduce plantar pressure as well as a custom-made shoe to accommodate the deformities. This patient has a Charcot deformity with extensive collapse of the skeletal architecture of the foot. Note that a toe is missing from a prior amputation. Deformities of this magnitude require custom-made insoles to reduce plantar pressure as well as a custom-made shoe to accommodate the deformities.