The Evaluation of OrCel for the Treatment of Venous Ulcers - Full Text View

Sponsored by:	Ortec International
Information provided by:	Ortec International
ClinicalTrials.gov Identifier:	NCT00270972

Purpose

This study was designed to confirm the clinical benefits and safety of OrCel in the treatment of venous ulcers. OrCel and standard care are compared to standard care alone. Standard care consists of currently accepted compression therapy.

Patients are treated for 12 weeks. Patients with healed ulcers are followed for an additional 12 weeks to assess durability of the healed wound.

Condition	Intervention
Venous Insufficiency Leg Ulcer	Device: Bilayered Cellular Matrix (OrCel)

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/Efficacy Study
Official Title:	A Confirmatory Study to Evaluate the Safety and Efficacy of Cryopreserved Bilayered Cellular Matrix (ORCEL) for the Treatment of Venous Ulcers

Further study details as provided by Ortec International:

Primary Outcome Measures:

Investigator Assessment of wound healing

Secondary Outcome Measures:

Planimetric assessment of wound healing
Photographic assessment of wound healing

Estimated Enrollment:	60
Study Start Date:	September 2005

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Any race, between 18 and 85 years of age
Male or female
Chronic venous insufficiency
Ulcer size between 2 and 20 sq cm, inclusive
Ulcer present for at least one month
ABI >0.7

Exclusion Criteria:

Decrease in wound size >35% during Screening Phase
Infection at ulcer site
Uncontrolled diabetes mellitus
Malnutrition
Previous treatment with excluded medications

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00270972

Locations

United States, Alabama
Baptist Medical Center South
Montgomery, Alabama, United States, 36116
United States, Arizona
Associated Foot and Ankle Specialists
Phoenix, Arizona, United States, 85015
United States, California
Eden Podiatry Group
Castro Valley, California, United States, 94546
PPH Center for Wound Care and Hyperbaric Medicine
Poway, California, United States, 92064
United States, Indiana
Wound Healing Center
Terre Haute, Indiana, United States, 47807
United States, New York
St Luke's Roosevelt
New York, New York, United States, 10025
Southside Hospital
Bay Shore, New York, United States, 11706
United States, Pennsylvania
Center for Advanced Wound Care
Reading, Pennsylvania, United States, 19601
Warren General Hospital
Warren, Pennsylvania, United States, 16365
United States, Wisconsin
Hyperbaric and Wound Care Associates
Milwaukee, Wisconsin, United States, 53215

Sponsors and Collaborators

Ortec International

More Information

Study ID Numbers:	100-VLU-02-CLN
Study First Received:	December 28, 2005
Last Updated:	June 2, 2006
ClinicalTrials.gov Identifier:	NCT00270972
Health Authority:	United States: Food and Drug Administration

Keywords provided by Ortec International:

Venous leg ulcer
Venous insufficiency
OrCel

Study placed in the following topic categories:

Varicose Ulcer
Varicose Veins
Skin Diseases
Ulcer

Venous Insufficiency
Vascular Diseases
Skin Ulcer
Leg Ulcer

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009