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A Study Of Pain And Quality Of Life Outcomes In Subjects With a Single Painful Venous Leg Ulcer Treated With Apligraf®

NCT02011724 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2013-12-13

No results posted yet for this study

Summary

The objective of the study is to demonstrate that treatment with Apligraf reduces venous leg ulcer (VLU)-related pain and improves the quality of life (QOL) of patients with a painful VLU.

Conditions

  • Venous Leg Ulcers

Interventions

DEVICE

Apligraf

Sponsors & Collaborators

  • Organogenesis

    lead INDUSTRY

Principal Investigators

  • William A. Marston, MD · Division of Vascular Surgery, UNC at Chapel Hill

  • Scott Gorenstein, MD · Winthrop University Hospital

  • David G. Armstrong, DPM, MD, PhD · Department of Surgery, University of Arizona College of Medicine

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2014-01-31
Completion
2014-01-31

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 NCT02011724 on ClinicalTrials.gov