Evaluation of Safety and Activity of Celaderm in Healing Venous Leg Ulcers

Study Overview
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Brief Summary
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This pilot study was designed to test the safety of Celaderm(TM) in treating venous leg ulcers and to give preliminary information about the efficacy of two different Celaderm(TM) dosing regimens.

Detailed Description
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Celaderm(TM) weekly for four weeks or biweekly for four treatments combined with Profore(R) compression vs. Profore(R) compression alone.

Official Title
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An Initial Evaluation Of The Safety And Activity Of Celaderm(TM) Treatment Regimens In Healing Venous Leg Ulcers

Conditions
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Leg Ulcer, Varicose Ulcer

Intervention / Treatment
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* Device: Celaderm (Frozen Cultured Epidermal Allograft)
* Device: Celaderm (Frozen Cultured Epidermal Allograft)
* Device: Control (compression bandaging)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: venous ulcer > 1 month and < 12 months in duration; 2 to 20 sq cm in surface area; not infected confirmatory venous ultrasound showing prior DVT and concurrent venous reflux ankle-brachial index 0.80 or greater Exclusion Criteria: cutaneous malignancy recent treatment with corticosteroids or chemotherapeutic agents wound exposed bone, tendon or neurovascular structure wound infected and requiring antibiotics

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Active Comparator: Control<br>Multi-layer compression bandaging (Profore) | Device: Control (compression bandaging)<br>* Multi-layer compression bandaging<br>* Other names: Profore;|
| Experimental: Celaderm, Bi-Weekly<br>Celaderm, bi-weekly applications, up to a maximum of four applications | Device: Celaderm (Frozen Cultured Epidermal Allograft)<br>* Four biweekly applications of Celaderm plus compression therapy<br>* Other names: Cultured Keratinocytes;|
| Experimental: Celaderm, Weekly<br>Celaderm, applied weekly, up to a maximum of four applications | Device: Celaderm (Frozen Cultured Epidermal Allograft)<br>* Four weekly applications of Celaderm plus compression therapy<br>* Other names: Cultured Keratinocytes;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Efficacy: Cumulative Proportion of Patients Completely Healed by the End of the Treatment Period, as Judged by the Investigator's Direct Observation. | The primary efficacy observation was the proportion of wounds that achieved complete wound closure after 12 weeks of active treatment (i.e. of of Week 15 including screening/wash-in phase.) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Efficacy: Proportion of Patients Achieving 90% Re-epithelialization After 12 Weeks of Active Treatment. | Re-epithelialization was judged by the Medical Monitor based upon computerized planimetry of serial wound photographs. | 12 Weeks | 
| Secondary Efficacy: Durability of Wound Closure Through 12 Weeks After the End of the Treatment Period. | The proportion of patients who had a recurrence of the study ulcer during follow-up after achieving wound closure during the active treatment period. | Variable - minimum of 12 weeks of follow-up. | 
| Secondary Efficacy: Cumulative Proportion of Patients Completely Healed by the End of the Follow-up Period (24 Weeks). | The proportion of patients achieving wound closure by the end of the study follow-up period, 90 days after the end of the active treatment period. | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wound, leg, venous, chronic, wound healing