Apligraf Versus Standard Therapy in the Treatment of Diabetic Foot Ulcers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Diabetic Foot

Intervention / Treatment
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* Device: Bi-layered cell therapy (Apligraf)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Bi-layered cell therapy (Apligraf)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to complete wound healing (full epithelialization with no drainage) |  | through 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of complete healing |  | at 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic foot