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The Evaluation of OrCel for the Treatment of Venous Ulcers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00270972
Recruitment Status : Unknown
Verified June 2006 by Ortec International.
Recruitment status was:  Active, not recruiting
First Posted : December 29, 2005
Last Update Posted : June 5, 2006
Information provided by:
Ortec International

Brief Summary:

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 or disease Intervention/treatment Phase
Venous Insufficiency Leg Ulcer Device: Bilayered Cellular Matrix (OrCel) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Confirmatory Study to Evaluate the Safety and Efficacy of Cryopreserved Bilayered Cellular Matrix (ORCEL) for the Treatment of Venous Ulcers
Study Start Date : September 2005

Primary Outcome Measures :
  1. Investigator Assessment of wound healing

Secondary Outcome Measures :
  1. Planimetric assessment of wound healing
  2. Photographic assessment of wound healing

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00270972

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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
Southside Hospital
Bay Shore, New York, United States, 11706
St Luke's Roosevelt
New York, New York, United States, 10025
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
Layout table for additonal information Identifier: NCT00270972    
Other Study ID Numbers: 100-VLU-02-CLN
First Posted: December 29, 2005    Key Record Dates
Last Update Posted: June 5, 2006
Last Verified: June 2006
Keywords provided by Ortec International:
Venous leg ulcer
Venous insufficiency
Additional relevant MeSH terms:
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Venous Insufficiency
Varicose Ulcer
Leg Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases
Vascular Diseases
Cardiovascular Diseases
Varicose Veins