Dermagraft(R) for the Treatment of Patients With Diabetic Foot Ulcers

Study Overview
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Brief Summary
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This study randomly assigns patients with plantar diabetic foot ulcers to receive conventional therapy (debridement, infection control, saline-moistened gauze dressings, and standardized off-weighting) alone or conventional therapy plus Dermagraft(R). Dermagraft is a device containing live human fibroblasts grown on an absorbable polyglactin (Vicryl) mesh. Patients are evaluated weekly until Week 12, then every four weeks until Week 32.

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

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Device: Dermagraft(R)
* Other: Conventional care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is 18 years old or older. Patient has a current diagnosis of NIDDM or IDDM. Patient's ulcer is present for a minimum of two weeks under the current Investigator's care The study ulcer has healed <50% in size during the two weeks leading up to randomization The study ulcer is on the plantar surface of the forefoot The ulcer is >/= 1.0 cm2 at Day 0 (the day of randomization). The ulcer extends through the dermis and into subcutaneous tissue but without exposure of muscle, tendon, bone, or joint capsule. The ulcer is free of necrotic debris and clinical infection and is comprised of healthy, vascular tissue and is suitable for skin grafting. The patient's Ankle-Arn Index by Doppler is >0.1 There is adequate circulation to the foot to allow for healing. The patient's diabetes is under control as determined by the Investigator. Female patients capable of bearing children must test negative for pregnancy and must use an acceptable 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. Exclusion Criteria: Patient has clinical evidence of gangrene on any part of the affected foot. The ulcer is over a Charcot deformity. The ulcer has a nondiabetic etiology. The ulcer has tunnels or sinus tracts that cannot be completely debrided. The patient's diabetes is uncontrolled and could interfere with the completion of the study. There is a medical condition(s) that in the Investigator's opinion make the patient an inappropriate candidate for this study. Patient has/had a malignant disease not in remission for 5 years or more. Patient has acute or chronic hepatitis, cirrhosis, has a serum albumin of <2.0 gms/dL, or has alkaline phosphatase or LDH at twice the upper limit of the normal range. Patient is receiving oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents, or is anticipated to require such agents during the course of the study. Patient has Acquired Immunodeficiency Syndrome (AIDS) or is infected with Human Immunodeficiency Virus (HIV). Patient has participated in another study utilizing an investigational drug or device within the previous 30 days. The ulcer has cellulitis, osteomyelitis, or other clinical evidence of infection. Patient has any condition(s) which seriously compromises their ability to complete this study.

Ages Eligible for Study
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Minimum Age: 18 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: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with complete wound closure |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with complete wound closure |  | 32 weeks | 
| Time to reach 25%,50%,75%, and 100% of wound closure |  | 32 weeks | 
| Percent of wound healed |  | 12 and 32 weeks | 
| Wound characterization |  | 32 weeks | 
| Recurrence of the ulcer |  | 32 weeks | 

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