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The Evaluation of OrCel for the Treatment of Venous Ulcers

Primary Purpose

Venous Insufficiency, Leg Ulcer

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bilayered Cellular Matrix (OrCel)
Sponsored by
Ortec International
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Insufficiency focused on measuring Venous leg ulcer, Venous insufficiency, OrCel

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 ulcer site Uncontrolled diabetes mellitus Malnutrition Previous treatment with excluded medications

Sites / Locations

  • Baptist Medical Center South
  • Associated Foot and Ankle Specialists
  • Eden Podiatry Group
  • PPH Center for Wound Care and Hyperbaric Medicine
  • Wound Healing Center
  • Southside Hospital
  • St Luke's Roosevelt
  • Center for Advanced Wound Care
  • Warren General Hospital
  • Hyperbaric and Wound Care Associates

Outcomes

Primary Outcome Measures

Investigator Assessment of wound healing

Secondary Outcome Measures

Planimetric assessment of wound healing
Photographic assessment of wound healing

Full Information

First Posted
December 28, 2005
Last Updated
June 2, 2006
Sponsor
Ortec International
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1. Study Identification

Unique Protocol Identification Number
NCT00270972
Brief Title
The Evaluation of OrCel for the Treatment of Venous Ulcers
Official Title
A Confirmatory 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
June 2006
Overall Recruitment Status
Unknown status
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Ortec International

4. Oversight

5. Study Description

Brief Summary
This study was designed to confirm the clinical benefits and safety of OrCel in the treatment of venous ulcers. OrCel and standard care are compared to standard care alone. Standard care consists of currently accepted compression therapy. Patients are treated for 12 weeks. Patients with healed ulcers are 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 Insufficiency, Leg Ulcer
Keywords
Venous leg ulcer, Venous insufficiency, OrCel

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (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 ulcer site Uncontrolled diabetes mellitus Malnutrition Previous treatment with excluded medications
Facility Information:
Facility Name
Baptist Medical Center South
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36116
Country
United States
Facility Name
Associated Foot and Ankle Specialists
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
Facility Name
Eden Podiatry Group
City
Castro Valley
State/Province
California
ZIP/Postal Code
94546
Country
United States
Facility Name
PPH Center for Wound Care and Hyperbaric Medicine
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
Wound Healing Center
City
Terre Haute
State/Province
Indiana
ZIP/Postal Code
47807
Country
United States
Facility Name
Southside Hospital
City
Bay Shore
State/Province
New York
ZIP/Postal Code
11706
Country
United States
Facility Name
St Luke's Roosevelt
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
Center for Advanced Wound Care
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19601
Country
United States
Facility Name
Warren General Hospital
City
Warren
State/Province
Pennsylvania
ZIP/Postal Code
16365
Country
United States
Facility Name
Hyperbaric and Wound Care Associates
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Evaluation of OrCel for the Treatment of Venous Ulcers

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