Apligraf Versus Standard Therapy in the Treatment of Diabetic Foot Ulcers

Phase 3

Terminated

• Conditions: Diabetic Foot

• Registration Number: NCT00512538
• Lead Sponsor: Organogenesis

Brief Summary

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

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.

Study Timeline

• Study Start: 2000-10
• Study Completion: 2002-09
• Status Verified: 2007-08
• Study First Submitted: 2007-08-03
• Study First Submitted QC: 2007-08-03
• Last Update Submitted: 2007-08-03
• Study First Posted: 2007-08-07
• Last Update Posted: 2007-08-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to complete wound healing (full epithelialization with no drainage)	through 12 weeks

Secondary Outcome Measures

Name	Time	Method
Incidence of complete healing	at 12 weeks