Evaluation of Bilayered Cellular Matrix (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: NCT00270946
Recruitment Status : Completed
First Posted : December 29, 2005
Last Update Posted : December 29, 2005
Information provided by:
Ortec International

Brief Summary:

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

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

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

Study Type : Interventional  (Clinical Trial)
Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pivotal Study to Evaluate the Safety and Efficacy of Cryopreserved Bilayered Cellular Matrix (OrCel) for the Treatment of Venous Ulcers
Study Start Date : April 2002
Study Completion Date : December 2003

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 the ulcer site
  • Uncontrolled diabetes mellitus
  • 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): NCT00270946

United States, Alabama
Terry Treadwell, MD
Montgomery, Alabama, United States, 33134
Sponsors and Collaborators
Ortec International Identifier: NCT00270946     History of Changes
Other Study ID Numbers: 100-VLU-01-CLN
First Posted: December 29, 2005    Key Record Dates
Last Update Posted: December 29, 2005
Last Verified: December 2005

Keywords provided by Ortec International:
Venous leg ulcer
Compression therapy

Additional relevant MeSH terms:
Leg Ulcer
Varicose Ulcer
Postphlebitic Syndrome
Postthrombotic Syndrome
Pathologic Processes
Skin Ulcer
Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Venous Insufficiency
Venous Thrombosis
Embolism and Thrombosis