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

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

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2003-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Venous Leg Ulcer Venous Stasis Ulcer

Keywords

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Venous leg ulcer OrCel Compression therapy

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 the ulcer site
* Uncontrolled diabetes mellitus
* Previous treatment with excluded medications

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Terry Treadwell, MD

Montgomery, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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100-VLU-01-CLN

Identifier Type: -

Identifier Source: org_study_id