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Safety and Efficacy of Apligraf in Nonhealing Wounds of Subjects With Junctional or Dystrophic Epidermolysis Bullosa (EB)

NCT00587223 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2010-06-29

Study results available
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Summary

The purpose of this study is to evaluate the use of Apligraf for the treatment of nonhealing wounds in subjects with dystrophic or junctional epidermolysis bullosa. Apligraf will be evaluated for efficacy and safety compared to a conventional nonadherent dressing. A matched-pair design will be used to evaluate Apligraf treatment versus conventional treatment in 68 study pairs.

Conditions

  • Epidermolysis Bullosa, Junctional
  • Epidermolysis Bullosa Dystrophica

Interventions

DEVICE

Apligraf

Up to 3 applications: Day 0, Month 1, Month 2.

OTHER

Standard dressing regimen

Dressing regimen will be comprised of a primary nonadherent dressing, nonstick gauze and standard dressing retainer

Sponsors & Collaborators

  • Organogenesis

    lead INDUSTRY

Principal Investigators

  • Elizabeth Alvarez- Connelly, MD · University of Miami

  • Damien Bates, MD, PhD, FRACS (Plast.) · Organogenesis Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2008-12-31
Completion
2008-12-31

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 NCT00587223 on ClinicalTrials.gov