Back to resultsEvaluation of Bilayered Cellular Matrix (OrCel) for the Treatment of Venous Ulcers
Primary Purpose
Venous Leg Ulcer, Venous Stasis Ulcer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bilayered Cellular Matrix (OrCel)
Sponsored by
About this trial
This is an interventional treatment trial for Venous Leg Ulcer focused on measuring Venous leg ulcer, OrCel, Compression therapy
Eligibility 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
Sites / Locations
- Terry Treadwell, MD
Outcomes
Primary Outcome Measures
Investigator assessment of wound healing
Secondary Outcome Measures
Planimetric assessment of wound healing
Photographic assessment of wound healing
Full Information
NCT ID
NCT00270946
First Posted
December 28, 2005
Last Updated
December 28, 2005
Sponsor
Ortec International
1. Study Identification
Unique Protocol Identification Number
NCT00270946
Brief Title
Evaluation of Bilayered Cellular Matrix (OrCel) for the Treatment of Venous Ulcers
Official Title
A Pivotal Study to Evaluate the Safety and Efficacy of Cryopreserved Bilayered Cellular Matrix (OrCel) for the Treatment of Venous Ulcers
Study Type
Interventional
2. Study Status
Record Verification Date
December 2005
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Ortec International
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Leg Ulcer, Venous Stasis Ulcer
Keywords
Venous leg ulcer, OrCel, Compression therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Bilayered Cellular Matrix (OrCel)
Primary Outcome Measure Information:
Title
Investigator assessment of wound healing
Secondary Outcome Measure Information:
Title
Planimetric assessment of wound healing
Title
Photographic assessment of wound healing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Terry Treadwell, MD
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
33134
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Bilayered Cellular Matrix (OrCel) for the Treatment of Venous Ulcers
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