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A Post Marketing Study of Apligraf in Non-healing Wounds of Subjects With Venous Leg Ulcers

NCT01327937 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-09-24

No results posted yet for this study

Summary

The overall study objective is to use microarray technology to identify and characterize the gene expression of multiple relevant genes in biopsies of non-healing venous ulcers.

Conditions

  • Venous Ulcer

Interventions

DEVICE

Apligraf

Apligraf group - Applied at Day 0, Weeks 1-4 (maximum of 5 applications) Also cross-over at Week 4 for Control NPTH group - Apligraf applied at Week 4, Weeks 5-8 (maximum of 5 applications)

OTHER

Standard of Care Dressing Group

Standard dressing regimen - Foam dressing (eg, Mepilex) and 4 layered compression system (eg, Profore)

Sponsors & Collaborators

  • Organogenesis

    lead INDUSTRY

Principal Investigators

  • Evangelos Badiavas, MD, PhD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2013-11-30
Completion
2013-12-31

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 NCT01327937 on ClinicalTrials.gov