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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

2006. American College of Physicians. All Rights Reserved.

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
2006. American College of Physicians. All Rights Reserved.

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

2006. American College of Physicians. All Rights Reserved.

2006. American College of Physicians. All Rights Reserved.

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

2006. American College of Physicians. All Rights Reserved.

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

2006. American College of Physicians. All Rights Reserved.

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


2006. American College of Physicians. All Rights Reserved.

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

2006. American College of Physicians. All Rights Reserved.

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

2006. American College of Physicians. All Rights Reserved.

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

2006. American College of Physicians. All Rights Reserved.

PATHOGENESIS OF DIABETIC FOOT ULCER AND AMPUTATION


Sensory
Joint
Neuropathy Mobility

Motor
Neuropathy

Autonomic
Neuropathy

Protective
sensation

Muscle atrophy and


2 foot deformities

Sweating
2 dry skin

Ischemia

Foot pressure
Minor trauma
recognition

Foot pressure
esp. over
bony prominences

Fissure

Healing

Callus

Pre-ulcer
ULCER
Minor Trauma:
Mechanical
Chemical
Thermal

PAD

Infection
AMPUTATION
Interdigital Maceration
(Moisture, Fungus)

2006. American College of Physicians. All Rights Reserved.

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

2006. American College of Physicians. All Rights Reserved.

CAUSAL PATHWAYS FOR FOOT ULCERS


NEUROPATHY

DEFORMITY

MINOR TRAUMA
- Mechanical (shoes)
- Thermal
- Chemical

% Causal Pathways
Neuropathy:
78%
Minor trauma:
79%
Deformity:
63%
Behavioral issues
?
POOR SELFFOOT CARE

ULCER
Diabetes Care 1999; 22:157
2006. American College of Physicians. All Rights Reserved.

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
2006. American College of Physicians. All Rights Reserved.

RISK STRATIFY FOR FOOT ULCERATION


Foot Ulcer,
Risk Level
3: prior amputation
prior ulcer

% Office Patients
%/yr
(diabetes clinics)
28.1%
7%
18.6%

2: insensate
and
foot deformity
or
absent pedal pulses

6.3%

10%

1: insensate

4.8%

17 - 30%

0: all normal

1.7%

66%
Diabetes Care 2001; 24:1442 Diabetes Metab 2003; 29:261

2006. American College of Physicians. All Rights Reserved.

ANNUAL DIABETIC FOOT EXAMS


2000 Behavioral Risk Factor Surveillance System, CDC

Total
% with foot
exam in
past year

63

Private MedicaidInsurance Medicare


64

65

VA

Uninsured

84*

48*

*p < 0.01
Health Services Research 2005; 40:361

2006. American College of Physicians. All Rights Reserved.

PHYSICAL EXAMINATION OF THE FEET


IN PERSONS WITH DIABETES

2006. American College of Physicians. All Rights Reserved.

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

2006. American College of Physicians. All Rights Reserved.

2006. American College of Physicians. All Rights Reserved.

2006. American College of Physicians. All Rights Reserved.

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

2006. American College of Physicians. All Rights Reserved.

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
2006. American College of Physicians. All Rights Reserved.

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)


2006. American College of Physicians. All Rights Reserved.

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

2006. American College of Physicians. All Rights Reserved.

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
2006. American College of Physicians. All Rights Reserved.

HX TO DETECT PAD IN DIABETES


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

(After Pompogelli and Campbell, 2002)

2006. American College of Physicians. All Rights Reserved.

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

2006. American College of Physicians. All Rights Reserved.

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

2006. American College of Physicians. All Rights Reserved.

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

2006. American College of Physicians. All Rights Reserved.

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

2006. American College of Physicians. All Rights Reserved.

OTHER EXAM FINDINGS FOR PAD


Helpful:
Femoral bruit (LR = 4.75.7)
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
2006. American College of Physicians. All Rights Reserved.

2006. American College of Physicians. All Rights Reserved.

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

2006. American College of Physicians. All Rights Reserved.

INTERPRETATION OF THE ABI

Normal
Mild obstruction
*Moderate obstruction
*Severe obstruction
**Poorly compressible
2 to medial Ca++

ABI
0.91-1.30
0.71-0.90
0.41-0.70
0.40
>1.30

*Poor ulcer healing with ABI 0.50


**Further vascular evaluation needed
2006. American College of Physicians. All Rights Reserved.

MOTOR NEUROPATHY AND FOOT DEFORMITIES


Hammer toes
Claw toes
Prominent metatarsal heads
Hallux valgus
Collapsed plantar arch
2006. American College of Physicians. All Rights Reserved.

Hammer
Toes

Claw Toes

From Levin and Pfeifer, The Uncomplicated Guide


to Diabetes Complications, 2002
2006. American College of Physicians. All Rights Reserved.

Hallux
Valgus

From Levin and Pfeifer, The Uncomplicated


Guide to Diabetes Complications, 2002
2006. American College of Physicians. All Rights Reserved.

From Boulton, et al Diabetic Medicine 1998, 15:508


2006. American College of Physicians. All Rights Reserved.

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
2006. American College of Physicians. All Rights Reserved.

2006. American College of Physicians. All Rights Reserved.

2006. American College of Physicians. All Rights Reserved.

2006. American College of Physicians. All Rights Reserved.

2006. American College of Physicians. All Rights Reserved.

2006. American College of Physicians. All Rights Reserved.

2006. American College of Physicians. All Rights Reserved.

2006. American College of Physicians. All Rights Reserved.

2006. American College of Physicians. All Rights Reserved.

2006. American College of Physicians. All Rights Reserved.

2006. American College of Physicians. All Rights Reserved.

2006. American College of Physicians. All Rights Reserved.

2006. American College of Physicians. All Rights Reserved.

2006. American College of Physicians. All Rights Reserved.

2006. American College of Physicians. All Rights Reserved.

2006. American College of Physicians. All Rights Reserved.

2006. American College of Physicians. All Rights Reserved.

RISK-STRATIFIED FOOTCARE
MANAGEMENT FOR DIABETES PATIENTS

2006. American College of Physicians. All Rights Reserved.

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
2006. American College of Physicians. All Rights Reserved.

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
2006. American College of Physicians. All Rights Reserved.

HIGH RISK: CATEGORY 1-3 PATIENTS


Nursing tasks to facilitate foot exams:
High Risk Feet stickers to each chart (Tool-Kit)
Remove patients 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

2006. American College of Physicians. All Rights Reserved.

www.ndep.nih.gov/diabetes/pubs/feet_kit_Eng.pdf
2006. American College of Physicians. All Rights Reserved.

2006. American College of Physicians. All Rights Reserved.

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

2006. American College of Physicians. All Rights Reserved.

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

2006. American College of Physicians. All Rights Reserved.

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)

2006. American College of Physicians. All Rights Reserved.

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
2006. American College of Physicians. All Rights Reserved.

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

2006. American College of Physicians. All Rights Reserved.

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

2006. American College of Physicians. All Rights Reserved.

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.

2006. American College of Physicians. All Rights Reserved.

EDUCATIONAL DEFICIENCIES:
HIGH RISK PATIENTS
558 high risk patients:
Deficiency
Not inspect feet regularly
Walk barefoot/stockings
Seldom/never test water temp.
Trim callus with sharp object
Not know to call ASAP for foot ulcer
Not know how to select footwear

From GE Reiber, 2003

% Deficient
50%
62%
40%
48%
58%
57%

2006. American College of Physicians. All Rights Reserved.

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
Diabetes Self-Management 2005; 22:33

2006. American College of Physicians. All Rights Reserved.

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

2006. American College of Physicians. All Rights Reserved.

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
2006. American College of Physicians. All Rights Reserved.

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
2006. American College of Physicians. All Rights Reserved.

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
2 RCTs

decreases ulcers 50-75%


no benefit

Benefits vary with footwear use, risk level?


Severe foot deformity, prior toe/ray amputation?
Diabetes Care 2004; 27:1774
2006. American College of Physicians. All Rights Reserved.

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
2006. American College of Physicians. All Rights Reserved.

2006. American College of Physicians. All Rights Reserved.

MEDICARE COVERAGE OF THERAPEUTIC FOOTWEAR


Medicare pays 80% of payment amount allowed:

Extra Depth shoes


Custom-made shoes
Diabetic Pre-fab Insoles
Diabetic Custom Insoles

Total Amount Amount Covered by


Allowed
Medicare
$132.00
$105.60
$396.00
$316.00
$67.00
$53.60
$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
2006. American College of Physicians. All Rights Reserved.

2006. American College of Physicians. All Rights Reserved.

2006. American College of Physicians. All Rights Reserved.

2006. American College of Physicians. All Rights Reserved.

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