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

December 28, 2005 updated by: Ortec International

A Pivotal Study to Evaluate the Safety and Efficacy of Cryopreserved Bilayered Cellular Matrix (OrCel) for the Treatment of Venous Ulcers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Montgomery, Alabama, United States, 33134
        • Terry Treadwell, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Investigator assessment of wound healing

Secondary Outcome Measures

Outcome Measure
Planimetric assessment of wound healing
Photographic assessment of wound healing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ortec International

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Study Completion

December 1, 2003

Study Registration Dates

First Submitted

December 28, 2005

First Submitted That Met QC Criteria

December 28, 2005

First Posted (Estimate)

December 29, 2005

Study Record Updates

Last Update Posted (Estimate)

December 29, 2005

Last Update Submitted That Met QC Criteria

December 28, 2005

Last Verified

December 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100-VLU-01-CLN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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