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Evaluation of Bilayered Cellular Matrix (OrCel) for the Treatment of Venous Ulcers

This study has been completed.
Information provided by:
Ortec International Identifier:
First received: December 28, 2005
Last updated: NA
Last verified: December 2005
History: No changes posted

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

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: 130
Study Start Date: April 2002
Estimated Study Completion Date: December 2003

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00270946

United States, Alabama
Terry Treadwell, MD
Montgomery, Alabama, United States, 33134
Sponsors and Collaborators
Ortec International
  More Information Identifier: NCT00270946     History of Changes
Other Study ID Numbers: 100-VLU-01-CLN 
Study First Received: December 28, 2005
Last Updated: December 28, 2005
Health Authority: United States: Food and Drug Administration

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 processed this record on October 21, 2016