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Long-Term Follow-Up to the DEVO Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers

NCT01891760 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2013-08-21

No results posted yet for this study

Summary

* Observe the long-term (1-year) outcomes of Dermagraft, compared with conventional treatment of four-layer compression bandaging therapy alone, in subjects who completed the ABH-Dermagraft-001-08 study.
* Study Hypothesis: N/A (Long-term follow-up study)

Conditions

  • Venous Leg Ulcer

Interventions

DEVICE

Dermagraft

Dermagraft treatment regimen of one application applied topically to the ulcer, weekly, for a maximum of 8 weeks (8 application maximum).

DEVICE

Profore

Four-layer compression bandaging therapy.

Sponsors & Collaborators

  • Shire Regenerative Medicine, Inc.

    lead INDUSTRY

Principal Investigators

  • Mollie Carter, MD · Shire Regenerative Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • United States
  • Estonia
  • Germany
  • Poland
  • South Africa
  • United Kingdom

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 NCT01891760 on ClinicalTrials.gov