Apligraf Versus Standard Therapy in the Treatment of Diabetic Foot Ulcers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-10-31

Study Completion Date

2002-09-30

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.

Conditions

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Diabetic Foot

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Bi-layered cell therapy (Apligraf)

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Michael E Edmonds, MD

Role: PRINCIPAL_INVESTIGATOR

Diabetic Foot Clinic, Kings College Hospital, London UK

Other Identifiers

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CGS0769 B304

Identifier Type: -

Identifier Source: org_study_id