The Evaluation of OrCel for the Treatment of Venous Ulcers

Sponsor

Ortec International (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00270972

Collaborator

(none)

Enrollment

Locations

Patients Per Site

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Venous Insufficiency Leg Ulcer	Device: Bilayered Cellular Matrix (OrCel)	N/A

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2005

Outcome Measures

Primary Outcome Measures

Investigator Assessment of wound healing []

Secondary Outcome Measures

Planimetric assessment of wound healing []
Photographic assessment of wound healing []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baptist Medical Center South	Montgomery	Alabama	United States	36116
2	Associated Foot and Ankle Specialists	Phoenix	Arizona	United States	85015
3	Eden Podiatry Group	Castro Valley	California	United States	94546
4	PPH Center for Wound Care and Hyperbaric Medicine	Poway	California	United States	92064
5	Wound Healing Center	Terre Haute	Indiana	United States	47807
6	Southside Hospital	Bay Shore	New York	United States	11706
7	St Luke's Roosevelt	New York	New York	United States	10025
8	Center for Advanced Wound Care	Reading	Pennsylvania	United States	19601
9	Warren General Hospital	Warren	Pennsylvania	United States	16365
10	Hyperbaric and Wound Care Associates	Milwaukee	Wisconsin	United States	53215