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

Leg Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00399308
• Other study ID #: P001-001-B
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 31, 2007
• Est. completion date: April 30, 2008

Study information

• Verified date: June 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 30, 2008
• Est. primary completion date: April 30, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

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:

• cutaneous malignancy

• recent treatment with corticosteroids or chemotherapeutic agents

• wound exposed bone, tendon or neurovascular structure

• wound infected and requiring antibiotics

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer

Intervention

Device:
• Celaderm (Frozen Cultured Epidermal Allograft)
Four biweekly applications of Celaderm plus compression therapy
• Celaderm (Frozen Cultured Epidermal Allograft)
Four weekly applications of Celaderm plus compression therapy
• Control (compression bandaging)
Multi-layer compression bandaging

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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	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