Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers

Study Overview
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Brief Summary
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This study randomly assigns patients with venous leg ulcers to receive standard therapy (compression) alone or compression 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 16-week treatment period is complete. Follow-up visits are conducted monthly for three months in order to assess patients for longer term safety.

Official Title
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A Prospective, Multi-Center, Randomized, Controlled Clinical Investigation of Dermagraft(R) in Subjects With Venous Leg Ulcers DEVO-Trial

Conditions
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Venous Leg Ulcer

Intervention / Treatment
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* Device: Dermagraft(R)
* Device: Profore


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 years of age ABI > 0.80 Three or fewer venous leg ulcers, if multiple must be separated by 2 cm Ultrasound demonstrates venous reflux >0.5 seconds Study wound present for 1-24 months Study wound 2-15 sq cm surface area Clean, granulating wound Patient able and willing to sign informed consent and comply with study procedures. Women of childbearing potential must use birth control pills, barriers or abstinence and have a negative pregnancy test. Exclusion Criteria: Wound etiology uncertain or not from venous hypertension. BMI>40 Acute or chronic infectious skin disease Allergy or intolerance to Profore(R) Wound infection, cellulitis, osteomyelitis >2 weeks' treatment with immunosuppressive agents in recent past Investigational drug use within 30 days Severe malnutrition, drug and/or alcohol abuse Malignant disease unless in remission for 5 years History of radiation at the study site Other conditions that could impede wound healing Known history of HIV or AIDS Prior participation in any Dermagraft study Treatment with other bioengineered tissue products within 30 days Unable to understand the aims and objectives of the trial Inability to comply with study protocol NYHA Class III or IV CHF Uncontrolled diabetes mellitus Dorsal foot ulcer

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement. | Device: Dermagraft(R)<br>* Weekly application of Dermagraft(R) with Profore compression as a secondary layer, in combination with systematic surgical wound debridement.<br>|
| Active Comparator: 2<br>Weekly application of compression dressings only, in combination with systematic surgical wound debridement. | Device: Profore<br>* Weekly application of Profore compression dressings, in combination with systematic surgical wound debridement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Healing of the Study Ulcer by Week 16. |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-to-Complete Healing | Kaplan-Meier survival analysis of the time to achieve median (50%) Complete Healing response in each treatment group. | From Week 0 visit to date subject's completely healed ulcer is 1st recorded as healed. If subject's ulcer not healed at 16 weeks, the time until CH was censored at 112 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Venous leg ulcer, randomized trial, clinical trial, Dermagraft, compression therapy, surgical debridement, venous stasis, chronic ulcer, chronic wound, fibroblasts