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

NCT00270946 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2005-12-29

No results posted yet for this study

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.

Conditions

  • Venous Leg Ulcer
  • Venous Stasis Ulcer

Interventions

DEVICE

Bilayered Cellular Matrix (OrCel)

Sponsors & Collaborators

  • Ortec International

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-04-30
Completion
2003-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00270946 on ClinicalTrials.gov