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

Phase 1

Completed

Interventions: Device: Celaderm (Frozen Cultured Epidermal Allograft)
Device: Control (compression bandaging)

Brief Summary: 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: Celaderm(TM) weekly for four weeks or biweekly for four treatments combined with Profore(R) compression vs. Profore(R) compression alone.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Celaderm, Bi-Weekly	Celaderm (Frozen Cultured Epidermal Allograft)	Celaderm, bi-weekly applications, up to a maximum of four applications
Celaderm, Weekly	Celaderm (Frozen Cultured Epidermal Allograft)	Celaderm, applied weekly, up to a maximum of four applications
Control	Control (compression bandaging)	Multi-layer compression bandaging (Profore)

Primary Outcome Measures

Name	Time	Method
Primary Efficacy: Cumulative Proportion of Patients Completely Healed by the End of the Treatment Period, as Judged by the Investigator's Direct Observation.	12 weeks	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.)

Secondary Outcome Measures

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

Locations (9): Center for Curative & Palliative Wound Care, Calvary Hospital
🇺🇸
Bronx, New York, United States
National Center for Limb Preservation
🇺🇸
Niles, Illinois, United States
Blair Medical Associates, Inc., Station Medical Center, Associates Wound Clinic
🇺🇸
Altoona, Pennsylvania, United States
Dixie Regional Medical Center, Wound Care
🇺🇸
Saint George, Utah, United States
State University of New York Stony Brook
🇺🇸
Stony Brook, New York, United States
University of North Carolina at Chapel Hill, Division of Vascular Surgery
🇺🇸
Durham, North Carolina, United States
Peripheral Vascular Associates, P.A.
🇺🇸
San Antonio, Texas, United States
Beth Israel Deaconess Medical Center, Division of Podiatry
🇺🇸
Boston, Massachusetts, United States
Dr. Robert Snyder
🇺🇸
Tamarac, Florida, United States