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

This study has been completed.
Sponsor:
Information provided by:
Ortec International
ClinicalTrials.gov Identifier:
NCT00270946
First received: December 28, 2005
Last updated: NA
Last verified: December 2005
History: No changes posted
  Purpose

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:

U.S. FDA Resources

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
  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 the ulcer site
  • Uncontrolled diabetes mellitus
  • Previous treatment with excluded medications
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00270946

Locations
United States, Alabama
Terry Treadwell, MD
Montgomery, Alabama, United States, 33134
Sponsors and Collaborators
Ortec International
  More Information

No publications provided

ClinicalTrials.gov 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
OrCel
Compression therapy

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

ClinicalTrials.gov processed this record on May 22, 2013