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Prevention of Diabetic Foot Ulcers and Lower Extremity Amputation Barry Stults, MD Scott A. Clark, DPM Thomas Miller, MD © 2007. American College of Physicians.

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Presentation on theme: "Prevention of Diabetic Foot Ulcers and Lower Extremity Amputation Barry Stults, MD Scott A. Clark, DPM Thomas Miller, MD © 2007. American College of Physicians."— Presentation transcript:

1 Prevention of Diabetic Foot Ulcers and Lower Extremity Amputation Barry Stults, MD Scott A. Clark, DPM Thomas Miller, MD © American College of Physicians. All rights reserved. This content has been excerpted from the ACP Clinical Skills Module, "Diabetic Foot Ulcers." For more information visit:

2 …the enormity of the global burden of diabetic foot disease…this much neglected, but potentially devastating, complication of a disease that is reaching epidemic proportions…Someone, somewhere, loses a leg because of diabetes every 30 seconds of everyday… Lancet. 2005;366:1674

3 Case Study 64-year-old obese man 64-year-old obese man Type 2 DM (15 yrs) Type 2 DM (15 yrs) BP (18 yrs) BP (18 yrs) Dyslipidemia(18 yrs) Dyslipidemia(18 yrs) CABG(10 yrs ago) CABG(10 yrs ago) Claudication(today; 25 yds) Claudication(today; 25 yds) Insulin/Metformin/Statin/ACEI/HCTZ/ASA Insulin/Metformin/Statin/ACEI/HCTZ/ASA Sore on my left foot, Doc Sore on my left foot, Doc

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5 Case Study (continued) Clinical evaluation of heel ulcer: Clinical evaluation of heel ulcer: Probe reached bone Probe reached bone Extensive subcutaneous abscess Extensive subcutaneous abscess MRI: extensive osteomyelitis MRI: extensive osteomyelitis ABI: 0.2 ABI: 0.2 Angiography: Inoperable severe vascular disease Angiography: Inoperable severe vascular disease Uncontrolled infection Uncontrolled infection Amputation necessary Amputation necessary

6 Amputations in Diabetes Common: U.S.A. – 80,000 amputations/year (2002) U.S.A. – 80,000 amputations/year (2002)Costly: $60,000/amputation $60,000/amputation $2 billion total costs annually $2 billion total costs annually Lancet. 2005;366:1719 Diabetes Care. 2004;27:1598 Diabetes Care. 2003;26:495

7 50% of amputations 50% of amputations 50% of patients 50% of patients Tragic Rule of 50 Transfemoral/ transtibial level 2 nd amputation in 5 years Die in 5 years Clinical Care of the Diabetic Foot, 2005

8 Tragic Rule of 15 15% of diabetes Foot ulcer in lifetime patients 15% of diabetes Foot ulcer in lifetime patients 15% of foot ulcers Osteomyelitis 15% of foot ulcers Osteomyelitis 15% of foot ulcers Amputation 15% of foot ulcers Amputation Clinical Care of the Diabetic Foot, 2005

9 Team Care Identification of high-risk patients Identification of high-risk patients Detection of early problems Detection of early problems Educate/motivate self-care behaviors Educate/motivate self-care behaviors Prophylactic nail/skin care Prophylactic nail/skin care Therapeutic footwear Therapeutic footwear Prompt, multidisciplinary treatment of ulcers Prompt, multidisciplinary treatment of ulcers Lancet. 2005;366:1676

10 Team Care Reduces Ulcers/Amputations 50%-80% reductions in ulcers/amputations 50%-80% reductions in ulcers/amputations Economic modeling studies Economic modeling studies Cost-effective if 25%-40% reduction in ulcer rate Cost-effective if 25%-40% reduction in ulcer rate Cost-saving if > 40% reduction in ulcer rate Cost-saving if > 40% reduction in ulcer rate Lancet. 2005;366:1719 Diabetes Care. 2004;27:901

11 Causal Pathways for Foot Ulcers Neuropathy Deformity ULCER % Causal Pathways Neuropathy: 78% Minor trauma:79% Deformity:63% Behavioral ? Diabetes Care. 1999; 22:157 Poor self-foot care Minor Trauma - Mechanical (shoes) - Thermal - Chemical

12 Detecting Feet-at-risk History: History: Prior amputation or foot ulcer Prior amputation or foot ulcer Peripheral artery disease (PAD) Peripheral artery disease (PAD) Exam: Exam: Insensate Insensate Foot deformities Foot deformities Absent pulses Absent pulses Prolonged venous filling time Prolonged venous filling time Reduced ABI Reduced ABI Pre-ulcerative cutaneous pathology Pre-ulcerative cutaneous pathology Arch Intern Med. 1998;158:157

13 Risk Stratify for Ulcer Risk Diabetes Care. 2001;24:1442 Diabetes Metab. 2003;29:261 Risk Level Foot Ulcer %/yr % Office Patients (diabetes clinics) 3: Prior amputation Prior ulcer 28.1% 18.6% 7% 2: Insensate and foot deformity or absent pedal pulses 6.3%10% 1: Insensate 4.8%17%-30% 0: All normal 1.7%66%

14 Annual Diabetic Foot Exams TotalPrivateInsuranceMedicaid-MedicareVAUninsured % with foot exam in past year *48* Health Services Research. 2005;40:361 *p < Behavioral Risk Factor Surveillance System, CDC

15 Physical Examination of the Feet in Persons with Diabetes

16 Sensory Neuropathy in Diabetes Loss of protective sensation in feet Loss of protective sensation in feet Detect with 5.07/10-g Semmes-Weinstein monofilament Detect with 5.07/10-g Semmes-Weinstein monofilament 50% of insensate patients have no symptoms 50% of insensate patients have no symptoms Diabetes Care. 2006;29(Suppl 1):S24 Diabetes Care. 2004;27:1591

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19 Monofilament Testing Test characteristics: Test characteristics: Negative predictive value = 90%-98% Negative predictive value = 90%-98% Positive predictive value = 18%-36% Positive predictive value = 18%-36% Prospective observational study: Prospective observational study: 80% of ulcers and 100% of amputations occur in insensate feet 80% of ulcers and 100% of amputations occur in insensate feet Superior predictive value vs. other test modalities Superior predictive value vs. other test modalities J Fam Pract. 2000;49:S30 Diabetes Care. 1992;15:1386

20 Using the Monofilament Demonstrate on forearm or hand Demonstrate on forearm or hand Place monofilament perpendicular to test site Place monofilament perpendicular to test site Bow into C-shape for 1 second Bow into C-shape for 1 second Test 4 sites/foot Test 4 sites/foot Heel testing does not predict ulcer Heel testing does not predict ulcer Avoid calluses, scars, and ulcers Avoid calluses, scars, and ulcers

21 Monofilament Testing Tips Insensate at 1 site = insensate feet Insensate at 1 site = insensate feet Falsely insensate with edema, cold feet Falsely insensate with edema, cold feet Test annually when sensation normal Test annually when sensation normal Use monofilament Use monofilament < 100 times day < 100 times day Replace if bent Replace if bent Replace every 3 months Replace every 3 months

22 Vibration Testing Biothesiometer Biothesiometer Best predictor of foot ulcer risk Best predictor of foot ulcer risk 128-Hz tuning fork at halluces 128-Hz tuning fork at halluces Equivalent to 10-g monofilament Equivalent to 10-g monofilament Newly recommended by ADA Newly recommended by ADA Diabetes Care. 2006;29(Suppl 1):S25 Diabetes Res Clin Pract. 2005;70:8

23 Motor Neuropathy and Foot Deformities Hammer toes Hammer toes Claw toes Claw toes Prominent metatarsal heads Prominent metatarsal heads Hallux valgus Hallux valgus Collapsed plantar arch Collapsed plantar arch

24 Hammer Toes Claw Toes © 2002 American Diabetes Association From The Uncomplicated Guide to Diabetes Complications Reprinted with permission from The American Diabetes Association

25 © 2002 American Diabetes Association From The Uncomplicated Guide to Diabetes Complications Reprinted with permission from The American Diabetes Association Hallux Valgus

26 Boulton, et al. Guidelines for Diagnosis of Outpatient Management of Diabetic Peripheral Neuropathy. Diabetic Medicine 1998, 15:

27 Pre-ulcer Cutaneous Pathology Persistent erythema after shoe removal Persistent erythema after shoe removal Callus Callus Callus with subcutaneous hemorrhage Callus with subcutaneous hemorrhage Fissure Fissure Interdigital maceration, fungal infection Interdigital maceration, fungal infection Nail pathology Nail pathology

28 AJM Boulton, H Connor, PR Cavanagh, The Foot in Diabetes, 2002 Pre-ulcer

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45 Peripheral Artery Disease Prevalence (ABI < 0.9): Prevalence (ABI < 0.9): 10%-20% in type 2 diabetes at diagnosis 10%-20% in type 2 diabetes at diagnosis 30% in diabetics age 50 years 30% in diabetics age 50 years 40%-60% in diabetics with foot ulcer 40%-60% in diabetics with foot ulcer Complications: Complications: Claudication Claudication Associated coronary and cerebral vascular disease Associated coronary and cerebral vascular disease Delayed ulcer healing Delayed ulcer healing Diabet Med. 2005;22:1310 Diabetes Care. 2003;26:3333

46 Pedal Pulse Examination Absent pedal pulses predicts severe PAD Absent pedal pulses predicts severe PAD Absence of a single pedal pulse does not predict PAD Absence of a single pedal pulse does not predict PAD Presence of pedal pulses does not rule out PAD! Presence of pedal pulses does not rule out PAD! Arch Intern Med. 1998;158:1357 Diabetes Care. 2003;26:3333

47 Venous Filling Time Sitting: Locate pedal vein bulging above skin Sitting: Locate pedal vein bulging above skin Supine: Elevate leg to 45° for 1 minute Supine: Elevate leg to 45° for 1 minute Sitting: Check time to pedal vein bulging Sitting: Check time to pedal vein bulging J Clin Epidemiol. 1997;50:659 Arch Intern Med. 1998;158:1357

48 Venous Filling Time Interpretation Filling Time Normal<20 sec Abnormal/collaterals20-40 sec Severe PAD>40 sec Filling time > 20 sec predicts ABI 20 sec predicts ABI < 0.5 Sensitivity, 22%; Specificity, 94%; LR, 3.9 Sensitivity, 22%; Specificity, 94%; LR, 3.9 J Clin Epidemiol. 1997;50:659 Arch Intern Med. 1998;158:1357

49 Adapted from: Norman PE, Eikelboom JW, Hankey GJ. Peripheral arterial disease: prognostic significance and prevention of atherothrombotic complications. Medical Journal of Australia 2004; 181: Figure 1, p.151

50 Ankle-Brachial Index Screening: 2004 ADA recommendation Screening: 2004 ADA recommendation Consider at age 50 years and every 5 years Consider at age 50 years and every 5 years Diagnosis: Diagnosis: Claudication, absent DP/PT pulses, foot ulcer Claudication, absent DP/PT pulses, foot ulcer Limitations: Limitations: Underestimates severity in calcified arteries Underestimates severity in calcified arteries Diabetes Care. 2005;28:2206 Diabetes Care. 2004;27(Suppl 1):S15-S35

51 Interpretation of the ABI InterpretationABI Normal Mild obstruction Moderate obstruction* Severe obstruction*<0.40 Poorly compressible**>1.30 2° to medial calcification *Poor ulcer healing with ABI < 0.50 **Further vascular evaluation needed

52 Risk-stratified Management of the Diabetic Foot

53 Low Risk Annual comprehensive foot examination Annual comprehensive foot examination Questionnaire completed by patient Questionnaire completed by patient Examination Examination Self-management and footwear education Self-management and footwear education Brief counseling Brief counseling Written handout Written handout JAMA. 2005;293:217

54 High Risk Annual comprehensive foot exam Annual comprehensive foot exam Inspect feet every office visit Inspect feet every office visit Podiatry care as needed Podiatry care as needed Intensive patient education Intensive patient education Detect/manage barriers to foot care Detect/manage barriers to foot care Therapeutic footwear, as needed Therapeutic footwear, as needed

55 High Risk: Nursing Tasks Place High-Risk Feet stickers on each chart Place High-Risk Feet stickers on each chart Remove patients shoes/socks Remove patients shoes/socks Determine if patient can reach/see soles of feet Determine if patient can reach/see soles of feet Stock 10-g monofilament in each room Stock 10-g monofilament in each room Consider training to perform monofilament exam Consider training to perform monofilament exam Provide patient education forms Provide patient education forms J Gen Intern Med. 2003;18:258

56 High Risk: Podiatry Care Provide nail and skin care Provide nail and skin care Assess footwear needs Assess footwear needs Visit frequency not evidence-based Visit frequency not evidence-based Diabetes Care. 2003;26:1691 J Fam Practice. 2000;49(Suppl):S30

57 High Risk: Patient Education Reinforce frequently – low retention Reinforce frequently – low retention Patient demonstrates self-care knowledge Patient demonstrates self-care knowledge Evidence: Evidence: May reduce foot ulcer/amputation rates May reduce foot ulcer/amputation rates Cochrane Database Syst Rev Jan 25;(1)CD Foot Ankle Int. 2005;26:38

58 Basic Foot Care Concepts Daily foot inspection Daily foot inspection May require mirror, magnification, or caregiver May require mirror, magnification, or caregiver Patient able to recognize/report: Patient able to recognize/report: Persistent erythema Persistent erythema Enlarging callus Enlarging callus Pre-ulcer (callus with hemorrhage) Pre-ulcer (callus with hemorrhage)

59 Basic Foot Care Concepts Commitment to self-care Commitment to self-care Wash/dry daily Wash/dry daily Lubricate daily (not between toes) Lubricate daily (not between toes) Debride callus/corn (low-risk patients) Debride callus/corn (low-risk patients) No self-cutting of nails if: No self-cutting of nails if: Neuropathy Neuropathy PAD PAD Poor vision Poor vision

60 Basic Foot Protective Behaviors Avoid temperature extremes Avoid temperature extremes No walking barefoot/stocking-footed No walking barefoot/stocking-footed Appropriate exercise for insensate feet Appropriate exercise for insensate feet Inspect shoes for foreign objects Inspect shoes for foreign objects Optimal footwear at all times Optimal footwear at all times

61 Basic Footwear Education Avoid: Pointed toes Pointed toes Slip-ons Slip-ons Open toes Open toes High heels High heels Plastic Plastic Black color Black color Too small Too small Favor: Broad-round toes Broad-round toes Adjustable (laces, buckles, Velcro) Adjustable (laces, buckles, Velcro) Athletic shoes, walking shoes Athletic shoes, walking shoes Leather, canvas Leather, canvas White/light colors White/light colors ½ between longest toe and end of shoe ½ between longest toe and end of shoe Diabetes Self-Management. 2005;22:33

62 Barriers to Foot Care Depression Depression Alcoholism Alcoholism Social isolation if unable to inspect feet Social isolation if unable to inspect feet Financial barriers Financial barriers Diab Metab Res Rev. 2004;20(Suppl 1):S13

63 Therapeutic Footwear Goals Protect feet Protect feet Reduce plantar pressure, shock, and shear Reduce plantar pressure, shock, and shear Accommodate, stabilize, support deformities Accommodate, stabilize, support deformities Suitable for occupation, home, leisure Suitable for occupation, home, leisure Diabetes Care. 2004;27:1832 Diab Metab Res Rev. 2004;20(Suppl1):S51

64 Therapeutic Footwear Components Padded socks (e.g., CoolMax, Duraspun, others) Padded socks (e.g., CoolMax, Duraspun, others) Shoe inserts/insoles (closed-cell foam, viscoelastic) Shoe inserts/insoles (closed-cell foam, viscoelastic) Therapeutic shoes Therapeutic shoes

65 Therapeutic Footwear Efficacy Decreases plantar pressure 50%-70% Decreases plantar pressure 50%-70% Uncertain reduction in ulcer rate Uncertain reduction in ulcer rate Diabetes Care. 2004;27:1774

66 Medicare Requirements Certify diabetic patient with foot at risk Certify diabetic patient with foot at risk Prescribe therapeutic footwear Prescribe therapeutic footwear Prepare/fit therapeutic footwear Prepare/fit therapeutic footwear Pedorthist, orthotist, prosthetist, D.P.M. Pedorthist, orthotist, prosthetist, D.P.M. Foot Ankle Int. 2005;26:42

67 Medicare Coverage Total Amount Allowed Amount Covered by Medicare Extra-depth shoes$132.00$ Custom-made shoes$396.00$ Diabetic pre-fab insoles$67.00$53.60 Diabetic custom insoles$67.00$53.60 Medicare pays 80% of payment amount allowed: Medicare pays 80% of payment amount allowed: 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

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71 Conclusion Diabetic foot ulcer is common Diabetic foot ulcer is common Foot ulcers have devastating consequences Foot ulcers have devastating consequences Screening is simple Screening is simple Screening and team care reduce diabetic foot ulcers and amputations Screening and team care reduce diabetic foot ulcers and amputations


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