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Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers

NCT00909870 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 537

Last updated 2018-06-18

Study results available
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Summary

This study randomly assigns patients with venous leg ulcers to receive standard therapy (compression) alone or compression plus Dermagraft(R). Dermagraft is a device containing live human fibroblasts grown on an absorbable Vicryl mesh. Patients are seen weekly until they heal or the 16-week treatment period is complete. Follow-up visits are conducted monthly for three months in order to assess patients for longer term safety.

Conditions

  • Venous Leg Ulcer

Interventions

DEVICE

Dermagraft(R)

Weekly application of Dermagraft(R) with Profore compression as a secondary layer, in combination with systematic surgical wound debridement.

DEVICE

Profore

Weekly application of Profore compression dressings, in combination with systematic surgical wound debridement.

Sponsors & Collaborators

  • Organogenesis

    lead INDUSTRY

Principal Investigators

  • William Marston, MD · University of North Carolina School of Medicine, Chapel Hill, NC

  • Keith Harding, MD · Cardiff University School of Medicine, Wales, UK

  • David Bergqvist, MD · University of Uppsala, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2011-05-31
Completion
2011-08-31

Countries

  • United States
  • Austria
  • Estonia
  • Germany
  • Poland
  • South Africa
  • Sweden
  • 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 NCT00909870 on ClinicalTrials.gov