Apligraf Versus Standard Therapy in the Treatment of Diabetic Foot Ulcers

Organogenesis

Status and phase

Terminated

Phase 3

Conditions

Diabetic Foot

Treatments

Device: Bi-layered cell therapy (Apligraf)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00512538

CGS0769 B304

Details and patient eligibility

About

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.

Full 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.

Enrollment

82 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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