4/7/2011

1

Diabetic Foot Ulcer Treatment and

PreventionAlexander Reyzelman DPM, FACFAS

Associate Professor California School of Podiatric Medicine at

Samuel Merritt University

Diabetic Foot Ulcers

� One of the most common complications of diabetes

� Annual incidence 1% to 4%1-2

� Lifetime risk 15% to 25%3-4

� ~15% of diabetic foot ulcers result in lower extremity amputation3,5

� ~85% of lower limb amputations in patients with diabetes are proceeded by ulceration6-7

� Peripheral neuropathy is a major contributing factor in diabetic foot ulcers1-7

� Other factors: foot deformity, callus, trauma, and peripheral vascular disease

1. Reiber and Ledoux. In The Evidence Base for Diabetes Care. Williams et al, eds. Hoboken, NJ: John Wiley & Sons 2002:641.

2. Boulton et al. NEJM. 2004;351:48.3. Sanders. J Am Podiatry Med Assoc. 1994;84:322.

4. Boulton et al. Lancet. 2005;366:1719.5. Ramsey et al. Diabetes Care 1999;22:382.6. Pecoraro et al. Diabetes Care. 1990;13:513.7. Apelqvist and Larsson. Diabetes Metab Res Rev.

2000:16:S75.

5-Year Mortality Rates

Armstrong et al. Int Wound J. 2007;Dec;4(4):286.

CA = Carcinoma.PAD = Peripheral artery disease.

In order to treat wounds, we must understand the factors associated with the etiology of those

wounds

4/7/2011

2

Wagner Classification

� Stage 0- pre-ulcerative lesion� Stage I- superficial with exposed sub Q� Stage II- down to tendon, ligament or

bone, not infected� Stage III- infected� Stage IV- localized gangrene of forefoot� Stage V - extensive gangrene

UT Diabetic Wound Classification System

0 1 2 3

A Pre orpostulcerative

lesion(epithelialized)

Superficial, notinvolving tendon,capsule or bone

Penetrates totendon orcapsule

Penetrates toBone

B INFECTION INFECTION INFECTION INFECTION

C ISCHEMIA ISCHEMIA ISCHEMIA ISCHEMIA

D INFECTION andISCHEMIA

INFECTION andISCHEMIA

INFECTION andISCHEMIA

INFECTION andISCHEMIA

1. Consensus Development Conference on Diabetic Foot Wound Care. ADA. Diabetes Care. 1999;22:1354-1360.

STANDARD TREATMENT FOR

DIABETIC FOOT ULCERS

Standard treatment modalities 1

� Sharp debridement of nonviable tissue

� Treatment of infection

� Saline-moistened dressings

� Off-loading to decrease pressure on extremity

� Arterial revascularization if indicated

� A wound that remains unhealed after 4 weeks is cause for concern, as it is associated with unfavorable outcomes, including amputation

Debridement

1) Debridement reduces the bio-burden2) potentially prevents an infection3) allows for better visualization and inspection of the wound. Steed and coworkers reported in their multi-center study that the patients that underwent debridement showed an improved healing response compared to the patients who did not undergo

debridement.

4/7/2011

3

� Continue until healthy bleeding soft tissue and/or bone are encountered

� Callus tissue surrounding the ulcer must be removed

� Regular debridement, typically weekly, can expedite the rate of wound healing and increase the probability of wound closure

Infection

� Secondary Signs of Infection

� Chronic exudate� Delayed healing� Friable granulation

tissue� Discolored

granulation tissue� Malodor� pocketing

Risk Factors for Foot Infections in Individuals with Diabetes

Lavery, et al Diabetes Care, Vol 29, Number 6, June 2006

Statistically significant risk factors for foot infection

� Wound depth to bone� Wound duration >30 days� Recurrent foot wound� Traumatic wound etiology� Peripheral vascular diseaseThe risk of developing an infection was 2,193 times greater in

subjects who develop a foot wound than in those without a wound

Pressure

� Is there too much pressure on the wound/ulcer

4/7/2011

4

Unaffected Limb S/P Partial First Ray and Charcot Af fected Limb

Photograph and scans courtesy of John S. Steinberg, DPM, University of Texas Health Science Center at San Antonio, San Antonio, Tex.

PLANTAR PRESSURES AND ULCERATION

Gold-Standard

� TCC� Multiple reports in

literature discussing reduction of peak plantar pressure on the forefoot and midfoot.

Removable Walker Boots

� Aircast

� Bledsoe

� DH Walker

DH Walker CROW

4/7/2011

5

Healing of Neuropathic Ulcers: Results of a Meta-analysis

� These data provide clinicians with a realistic assessment of their chances of healing neuropathic ulcers

� Even with good, standard wound care, healing neuropathic ulcers in patients with diabetes continues to be a challenge

Margolis et al. Diabetes Care. 1999;22:692.

GOOD WOUND CARE x 4 weeks

50% Healed?

Continue with treatment

Change to “Advanced Wound Healing”

YES NO

Advanced Wound Management

Types of Products

� Negative Pressure � Collagen� Growth Factor

� Acellular Dermal Matrix� Bioengineered Skin

� Dermagraft� Apligraf

Protective Footwear:Permanent Shoes

4/7/2011

6

Thank YouTissue Engineering

Dermal fibroblasts are seeded ontoa bioabsorbable scaffold

After 2 weeks, a living dermal substitute has formed which can support the migration, proliferation and stratification of an epidermis

Growing living human dermal substitutes

*The persistence of Apligraf cells on the wound and the safety of this device in venous ulcer patients beyond 1 year and in diabetic foot ulcer patients beyond 6 months have not been evaluate

What is Apligraf?Product Description

� Supplied as a living, bi-layered skin substitute*Indications :

� Venous Leg Ulcers� Diabetic Foot Ulcers

Well-tolerated in over 12,000 patient applications

4/7/2011

7

Histological cross-section of DERMAGRAFT

DERMAGRAFT from the Package

Dermagraft ®