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

This study is ongoing, but not recruiting participants.

First Received: November 10, 2006 Last Updated: October 23, 2007 History of Changes

Sponsored by:	Advanced BioHealing, Inc.
Information provided by:	Advanced BioHealing, Inc.
ClinicalTrials.gov Identifier:	NCT00399308

Purpose

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.

Condition	Intervention	Phase
Leg Ulcer Varicose Ulcer	Device: Celaderm(TM)	Phase I Phase II

MedlinePlus related topics: Leg Injuries and Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Official Title:	An Initial Evaluation Of The Safety And Activity Of Celaderm(TM) Treatment Regimens In Healing Venous Leg Ulcers

Further study details as provided by Advanced BioHealing, Inc.:

Primary Outcome Measures:

Adverse events: wound infections, immunologic reactions

Secondary Outcome Measures:

Complete wound closure at 12 weeks
Rates of wound healing

Estimated Enrollment:	55
Study Start Date:	December 2006
Estimated Study Completion Date:	October 2007

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

venous ulcer > 1 month and < 12 months in duration; 2 - 18 sq cm in surface area; not infected; confirmatory venous ultrasound showing old deep venous thrombosis or venous reflux

Exclusion Criteria:

ankle-brachial index less than 0.8;
cutaneous malignancy;
recent treatment with corticosteroids or chemotherapeutic agents

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00399308

Locations

United States, Florida
Dr. Robert Snyder
Tamarac, Florida, United States, 33321
United States, Illinois
National Center for Limb Preservation
Niles, Illinois, United States, 60714
United States, Massachusetts
Beth Israel Deaconess Medical Center, Division of Podiatry
Boston, Massachusetts, United States, 02215
United States, New York
State University of New York Stony Brook
Stony Brook, New York, United States, 11794
Center for Curative & Palliative Wound Care, Calvary Hospital
Bronx, New York, United States, 10461
United States, North Carolina
University of North Carolina at Chapel Hill, Division of Vascular Surgery
Durham, North Carolina, United States, 27599
United States, Pennsylvania
Blair Medical Associates, Inc., Station Medical Center, Associates Wound Clinic
Altoona, Pennsylvania, United States, 16602
United States, Texas
Peripheral Vascular Associates, P.A.
San Antonio, Texas, United States, 78205
United States, Utah
Dixie Regional Medical Center, Wound Care
Saint George, Utah, United States, 84770

Sponsors and Collaborators

Advanced BioHealing, Inc.

Investigators

Study Director:

David E Eisenbud, MD

Advanced BioHealing, Inc.

More Information

No publications provided

Study ID Numbers:	P001-001-B
Study First Received:	November 10, 2006
Last Updated:	October 23, 2007
ClinicalTrials.gov Identifier:	NCT00399308 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Advanced BioHealing, Inc.:

wound
leg
venous
chronic
wound healing

Study placed in the following topic categories:

Varicose Ulcer
Varicose Veins
Skin Diseases
Ulcer

Vascular Diseases
Skin Ulcer
Leg Ulcer

Additional relevant MeSH terms:

Varicose Ulcer
Pathologic Processes
Varicose Veins
Skin Diseases
Ulcer

Vascular Diseases
Cardiovascular Diseases
Skin Ulcer
Leg Ulcer

ClinicalTrials.gov processed this record on May 07, 2009