Apligraf Versus Standard Therapy in the Treatment of Diabetic Foot Ulcers

A Randomized, Open-Label, Multi-Center Study to Compare the Safety and Efficacy of Apligraf Versus Standard Therapy (i.e., Saline Moistened Dressing Regimen) in the Treatment of Diabetic (Primarily Neuropathic) Foot Ulcers

The purpose of this study is to determine the ability of Apligraf to improve the time to and incidence of complete wound closure of diabetic foot ulcers, as compared to diabetic foot ulcers treated with standard therapy.

Ulceration of the diabetic foot is a result of multiple problems including repetitive stress on a neuropathic or insensate area that is often associated with an underlying bony prominence. By healing diabetic foot ulcers quickly the risks of infection, osteomyelitis (infeciton of the bone) and limb loss can be reduced.

This study will evaluate the ability of Apligraf to heal diabetic foot ulcers that have been present for at least 2 weeks and are between 1 - 16 cm2 in area. Patients will be randomized to either (50:50 chance) treatment with Apligraf or a saline moistened dressing regimen (standard therapy). All patients will receive standard cares for the ulcers which includes debridement, orthotics and off-loading throughout the treatment period.

Inclusion Criteria:

• diabetic ulcer of primarily neuropathic origin on the plantar region of the forefoot
• ulcer extending through the dermis but without sinus tract, tendon, capsule or bone exposure
• ulcer present for at least 2 weeks and measuring 1- 16 cm2
• diminished sensesation on target extremity/foot
• ulcer is not infected
• Type 1 or 2 diabetes with adequate glycemic control
• Adequate vascular supply to the target extremity

Exclusion Criteria:

• Charcot foot
• Non-neuropathic ulcers
• Skin cancer within or adjacent to the target ulcer
• Osteomyelitis or an infected ulcer
• Clinically significant medical condition that would impair wound healing
• Females who are pregnant
• Received within 4 weeks of study entry systemic corticosteriods, immunosuppresive agents, radiation therapy or chemotherapy