Pivotal Trial of Dermagraft(R) to Treat Diabetic Foot Ulcers

Study Overview
=================
Brief Summary
-----------------
This study randomly assigns patients with diabetic foot ulcers to receive standard therapy (surgical debridement, saline-moistened gauze and offloading) alone or standard therapy plus Dermagraft(R). Dermagraft is a device containing live human fibroblasts grown on an absorbable Vicryl mesh. Patients are seen weekly until they heal or the 12-week treatment period is complete.

Official Title
-----------------
A Prospective, Multicenter, Randomized, Single-Blind, Phase III, Clinical Investigation of Dermagraft(R) in Patients With Plantar Diabetic Foot Ulcers

Conditions
-----------------
Diabetic Foot Ulcer

Intervention / Treatment
-----------------
* Device: Dermagraft
* Other: Comparator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is 18 years of age or older. Patient has type I or II diabetes. Foot ulcer has been present for a minimum of 2 weeks under the current investigator's care. Foot ulcer is on the plantar surface of the forefoot or heel. Ulcer size is >/=1.0 cm2 at Day 0 (day of randomization). Ulcer extends through the dermis and into subcutaneous tissue but without exposure of muscle, tendon, bone, or joint capsule. Ulcer is free of necrotic debris, exhibits no signs of clinical infection, and appears to be made up of healthy vascularized tissue. Patient's Ankle-Arm Index by Doppler is >/=0.7. Patient has adequate circulation to the foot as evidenced by a palpable pulse. Female patients of child bearing potential must not be pregnant and must use accepted means of birth control. Patient and caregiver are willing to participate in the clinical study and can comply with the follow-up regimen. Patient or his/her legal representative has read and signed the Institutional Review Board (IRB) approved Informed Consent form before treatment. Patient's study ulcer has been present (open) for at least 6 weeks at the time of the Screening visit. Exclusion Criteria: There is clinical evidence of gangrene on any part of the affected foot. The study ulcer is over a Charcot deformity. The study ulcer is due to a nondiabetic etiology. The ulcer has tunnels or sinus tracts that cannot be completely debrided. The ulcer is >20 cm2 (longest dimension cannot be greater than 5 cm). The ulcer has increased or decreased in size by 50% or more during the screening period. Presence of medical condition(s) that in the Investigator's opinion makes the patient an inappropriate candidate for this study. Presence of a malignant disease not in remission for 5 years or more. Evidence of severe malnutrition, based on a serum albumin level <2.0. Presence of patient having known alcohol or drug abuse. A random blood sugar reading >/=450 mg/dL. Presence of urine ketones that are noted to be Small, Moderate, or Large. Presence of a nonstudy ulcer on the study foot within 7.0 cm of the study ulcer at Day 0. Use of oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents, Coumadin or heparin during the study. A history of bleeding disorder. Presence of Acquired Immunodeficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV). Participation in another study involving treatment with an investigational product within the previous 30 days. Elective osseous procedures to the study foot within 30 days prior to the Screening visit. Previous treatment with Dermagraft®. Presence in study ulcer of cellulitis, osteomyelitis or other clinical evidence of infection. Presence of condition(s) that seriously compromise the patient's ability to complete this study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dermagraft(R)<br>Weekly application of Dermagraft(R) with standard care | Device: Dermagraft<br>* Weekly application of Dermagraft(R) with standard care<br>* Other names: human fibroblast derived dermal substitute;|
| Other: Standard care only<br>Weekly application of standard care | Other: Comparator<br>* Weekly application of standard care<br>* Other names: standard of care, off-loading, surgical debridement, wet-to-moist dressing;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete wound closure |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to reach complete wound closure |  | 12 weeks | 
| Percent of wound closure by study end |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetic foot ulcer, Randomized trial, Clinical trial, Dermagraft, Standard care