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The Evaluation of OrCel for the Treatment of Venous Ulcers

NCT ID: NCT00270972

Last Updated: 2006-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Venous Insufficiency Leg Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Bilayered Cellular Matrix (OrCel)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ortec International

INDUSTRY

Sponsor Role lead

Locations

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Baptist Medical Center South

Montgomery, Alabama, United States

Site Status

Associated Foot and Ankle Specialists

Phoenix, Arizona, United States

Site Status

Eden Podiatry Group

Castro Valley, California, United States

Site Status

PPH Center for Wound Care and Hyperbaric Medicine

Poway, California, United States

Site Status

Wound Healing Center

Terre Haute, Indiana, United States

Site Status

Southside Hospital

Bay Shore, New York, United States

Site Status

St Luke's Roosevelt

New York, New York, United States

Site Status

Center for Advanced Wound Care

Reading, Pennsylvania, United States

Site Status

Warren General Hospital

Warren, Pennsylvania, United States

Site Status

Hyperbaric and Wound Care Associates

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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100-VLU-02-CLN

Identifier Type: -

Identifier Source: org_study_id