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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00270946
First Posted: December 29, 2005
Last Update Posted: December 29, 2005
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.
Information provided by:
Ortec International
  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: 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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT00270946


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

ClinicalTrials.gov Identifier: NCT00270946     History of Changes
Other Study ID Numbers: 100-VLU-01-CLN
First Submitted: December 28, 2005
First Posted: December 29, 2005
Last Update Posted: December 29, 2005
Last Verified: December 2005

Keywords provided by Ortec International:
Venous leg ulcer
OrCel
Compression therapy

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