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

Shire40 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Leg Ulcer Varicose Ulcer

Interventions

Celaderm (Frozen Cultured Epidermal Allograft)DEVICE

Four biweekly applications of Celaderm plus compression therapy

Celaderm (Frozen Cultured Epidermal Allograft)DEVICE

Four weekly applications of Celaderm plus compression therapy

Control (compression bandaging)DEVICE

Multi-layer compression bandaging

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (9)

Dr. Robert Snyder

Tamarac, Florida, United States

National Center for Limb Preservation

Niles, Illinois, United States

Beth Israel Deaconess Medical Center, Division of Podiatry

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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.)

Time frame: 12 weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 24 weeks

Data from ClinicalTrials.gov

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