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Prevention ofDiabetic Foot Ulcers and
Lower Extremity Amputation
Barry Stults, MD
Scott A. Clark, DPM
Thomas Miller, MD
© 2007. 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: http://www.acponline.org/clinicalskills/
“…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
Case Study
64-year-old obese man
Type 2 DM (15 yrs) BP (18 yrs) Dyslipidemia (18 yrs) CABG (10 yrs ago) Claudication (today; 25 yds)
Insulin/Metformin/Statin/ACEI/HCTZ/ASA
“Sore on my left foot, Doc”
Case Study (continued)
Clinical evaluation of heel ulcer: Probe reached bone Extensive subcutaneous abscess
MRI: extensive osteomyelitis
ABI: 0.2
Angiography: Inoperable severe vascular disease
Uncontrolled infection
Amputation necessary
Amputations in Diabetes
Common:
U.S.A. – 80,000 amputations/year (2002)
Costly:
$60,000/amputation
$2 billion total costs annually
Lancet. 2005;366:1719
Diabetes Care. 2004;27:1598
Diabetes Care. 2003;26:495
50% ofamputations
50% of patients
50% of patients
Tragic “Rule of 50”
Transfemoral/transtibial level
2nd amputation in 5 years
Die in 5 years
Clinical Care of the Diabetic Foot, 2005
Tragic “Rule of 15”
15% of diabetes Foot ulcer in lifetimepatients
15% of foot ulcers Osteomyelitis
15% of foot ulcers Amputation
Clinical Care of the Diabetic Foot, 2005
Team Care
Identification of high-risk patients
Detection of early problems
Educate/motivate self-care behaviors
Prophylactic nail/skin care
Therapeutic footwear
Prompt, multidisciplinary treatment of ulcers
Lancet. 2005;366:1676
Team Care Reduces Ulcers/Amputations
50%-80% reductions in ulcers/amputations
Economic modeling studies
Cost-effective if 25%-40% reduction in ulcer rate Cost-saving if > 40% reduction in ulcer rate
Lancet. 2005;366:1719
Diabetes Care. 2004;27:901
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
Detecting Feet-at-risk
History: Prior amputation or foot ulcer Peripheral artery disease (PAD)
Exam: Insensate Foot deformities Absent pulses Prolonged venous filling time Reduced ABI Pre-ulcerative cutaneous pathology
Arch Intern Med. 1998;158:157
Risk Stratify for Ulcer Risk
Diabetes Care. 2001;24:1442
Diabetes Metab. 2003;29:261
Risk LevelFoot Ulcer
%/yr% Office Patients(diabetes clinics)
3: Prior amputationPrior ulcer
28.1%18.6%
7%
2: Insensate andfoot deformity orabsent pedalpulses
6.3% 10%
1: Insensate 4.8% 17%-30%
0: All normal 1.7% 66%
Annual Diabetic Foot Exams
TotalPrivate
InsuranceMedicaid-Medicare VA Uninsured
% with footexam in past year
63 64 65 84* 48*
Health Services Research. 2005;40:361
*p < 0.01
2000 Behavioral Risk Factor Surveillance System, CDC
Physical Examination of the Feet
in Persons with Diabetes
Sensory Neuropathy in Diabetes
Loss of protective sensation in feet
Detect with 5.07/10-g Semmes-Weinstein monofilament
50% of insensate patients have no symptoms
Diabetes Care. 2006;29(Suppl 1):S24
Diabetes Care. 2004;27:1591
Monofilament Testing
Test characteristics:
Negative predictive value = 90%-98% Positive predictive value = 18%-36%
Prospective observational study:
80% of ulcers and 100% of amputations occur in insensate feet
Superior predictive value vs. other test modalities
J Fam Pract. 2000;49:S30
Diabetes Care. 1992;15:1386
Using the Monofilament
Demonstrate on forearm or hand
Place monofilament perpendicular to test site
Bow into C-shape for 1 second
Test 4 sites/foot
Heel testing does not predict ulcer
Avoid calluses, scars, and ulcers
Monofilament Testing Tips
Insensate at 1 site = insensate feet
Falsely insensate with edema, cold feet
Test annually when sensation normal
Use monofilament < 100 times day Replace if bent Replace every 3 months
Vibration Testing
Biothesiometer
Best predictor of foot ulcer risk
128-Hz tuning fork at halluces
Equivalent to 10-g monofilament Newly recommended by ADA
Diabetes Care. 2006;29(Suppl 1):S25
Diabetes Res Clin Pract. 2005;70:8
Motor Neuropathy and Foot Deformities
Hammer toes
Claw toes
Prominent metatarsal heads
Hallux valgus
Collapsed plantar arch
Hammer Toes
Claw Toes
© 2002 American Diabetes AssociationFrom The Uncomplicated Guide to Diabetes ComplicationsReprinted with permission from The American Diabetes Association
© 2002 American Diabetes AssociationFrom The Uncomplicated Guide to Diabetes ComplicationsReprinted with permission from The American Diabetes Association
Hallux Valgus
Boulton, et al. Guidelines for Diagnosis of Outpatient Management of Diabetic Peripheral Neuropathy. Diabetic Medicine 1998, 15:508-512
Pre-ulcer Cutaneous Pathology
Persistent erythema after shoe removal
Callus
Callus with subcutaneous hemorrhage
Fissure
Interdigital maceration, fungal infection
Nail pathology
AJM Boulton, H Connor, PR Cavanagh, The Foot in Diabetes, 2002
Pre-ulcer
Peripheral Artery Disease
Prevalence (ABI < 0.9): 10%-20% in type 2 diabetes at diagnosis 30% in diabetics age 50 years 40%-60% in diabetics with foot ulcer
Complications: Claudication Associated coronary and cerebral vascular
disease Delayed ulcer healing
Diabet Med. 2005;22:1310
Diabetes Care. 2003;26:3333
Pedal Pulse Examination
Absent pedal pulses predicts severe PAD
Absence of a single pedal pulse does not predict PAD
Presence of pedal pulses does not rule out PAD!
Arch Intern Med. 1998;158:1357
Diabetes Care. 2003;26:3333
Venous Filling Time
Sitting: Locate pedal vein bulging above skin
Supine: Elevate leg to 45° for 1 minute
Sitting: Check time to pedal vein bulging
J Clin Epidemiol. 1997;50:659
Arch Intern Med. 1998;158:1357
Venous Filling Time Interpretation
Filling Time
Normal <20 sec
Abnormal/collaterals 20-40 sec
Severe PAD >40 sec
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
Adapted from: 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
Ankle-Brachial Index
Screening: 2004 ADA recommendation
“Consider” at age 50 years and every 5 years
Diagnosis:
Claudication, absent DP/PT pulses, foot ulcer
Limitations:
Underestimates severity in calcified arteries
Diabetes Care. 2005;28:2206
Diabetes Care. 2004;27(Suppl 1):S15-S35
Interpretation of the ABI
Interpretation ABI
Normal 0.90-1.30
Mild obstruction 0.70-0.89
Moderate obstruction* 0.40-0.69
Severe obstruction* <0.40
Poorly compressible** >1.30
2° to medial calcification
*Poor ulcer healing with ABI < 0.50**Further vascular evaluation needed
Risk-stratified Management of the Diabetic Foot
Low Risk
Annual comprehensive foot examination
Questionnaire completed by patient Examination
Self-management and footwear education
Brief counseling Written handout
JAMA. 2005;293:217
High Risk
Annual comprehensive foot exam
Inspect feet every office visit
Podiatry care as needed
Intensive patient education
Detect/manage barriers to foot care
Therapeutic footwear, as needed
High Risk: Nursing Tasks
Place “High-Risk Feet” stickers on each chart
Remove patient’s shoes/socks
Determine if patient can reach/see soles of feet
Stock 10-g monofilament in each room
Consider training to perform monofilament exam
Provide patient education forms
J Gen Intern Med. 2003;18:258
High Risk: Podiatry Care
Provide nail and skin care
Assess footwear needs
Visit frequency not evidence-based
Diabetes Care. 2003;26:1691
J Fam Practice. 2000;49(Suppl):S30
High Risk: Patient Education
Reinforce frequently – low retention
Patient demonstrates self-care knowledge
Evidence: May reduce foot ulcer/amputation rates
Cochrane Database Syst Rev. 2005 Jan 25;(1)CD001488
Foot Ankle Int. 2005;26:38
Basic Foot Care Concepts
Daily foot inspection
May require mirror, magnification, or caregiver
Patient able to recognize/report:
Persistent erythema Enlarging callus Pre-ulcer (callus with hemorrhage)
Basic Foot Care Concepts
Commitment to self-care
Wash/dry daily
Lubricate daily (not between toes)
Debride callus/corn (low-risk patients)
No self-cutting of nails if:
Neuropathy PAD Poor vision
Basic Foot Protective Behaviors
Avoid temperature extremes
No walking barefoot/stocking-footed
Appropriate exercise for insensate feet
Inspect shoes for foreign objects
Optimal footwear at all times
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
½” between longest toe and end of shoe
Diabetes Self-Management. 2005;22:33
Barriers to Foot Care
Depression
Alcoholism
Social isolation if unable to inspect feet
Financial barriers
Diab Metab Res Rev. 2004;20(Suppl 1):S13
Therapeutic Footwear Goals
Protect feet
Reduce plantar pressure, shock, and shear
Accommodate, stabilize, support deformities
Suitable for occupation, home, leisure
Diabetes Care. 2004;27:1832
Diab Metab Res Rev. 2004;20(Suppl1):S51
Therapeutic Footwear Components
Padded socks (e.g., CoolMax, Duraspun, others)
Shoe inserts/insoles (closed-cell foam, viscoelastic)
Therapeutic shoes
Therapeutic Footwear Efficacy
Decreases plantar pressure 50%-70%
Uncertain reduction in ulcer rate
Diabetes Care. 2004;27:1774
Medicare Requirements
Certify diabetic patient with foot at risk
Prescribe therapeutic footwear
Prepare/fit therapeutic footwear
Pedorthist, orthotist, prosthetist, D.P.M. www.cpeds.org
Foot Ankle Int. 2005;26:42
Medicare Coverage
Total Amount Allowed
Amount Covered by Medicare
Extra-depth shoes $132.00 $105.60
Custom-made shoes $396.00 $316.00
Diabetic pre-fab insoles $67.00 $53.60
Diabetic custom insoles $67.00 $53.60
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
Conclusion
Diabetic foot ulcer is common
Foot ulcers have devastating consequences
Screening is simple
Screening and team care reduce diabetic foot ulcers and amputations