Apligraf Versus Standard Therapy in the Treatment of Diabetic 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Time to complete wound healing (full epithelialization with no drainage) [ Time Frame: through 12 weeks ]
- Incidence of complete healing [ Time Frame: at 12 weeks ]
|Study Start Date:||October 2000|
|Study Completion Date:||September 2002|
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.