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NCT00909870 · ClinicalTrials.gov registry record · Phase 3
Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers
A Phase 3 study of Venous Leg Ulcer, sponsored by Organogenesis.
- Completed
- Registry status
- Phase 3
- Development phase
- 537
- Enrollment target
- 20
- Study locations
NCT00909870: Completed Phase 3 study of Venous Leg Ulcer, sponsored by Organogenesis.
NCT00909870 is a Phase 3 study of Venous Leg Ulcer that has completed, run by Organogenesis. The registered enrollment target is 537 participants, above the 230-participant average among 35 other Venous Leg Ulcer trials with a reported enrollment target (133% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00909870, a Phase 3 study of Venous Leg Ulcer, has completed, sponsored by Organogenesis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 537 participants
- Enrollment target
- 20
- Study locations
Study 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 Studied
Interventions
- DEVICE Dermagraft(R)
- DEVICE Profore
Study Locations (20)
Florida
- Foot & Ankle Associates of Florida - Altamonte Springs
- Bay Pines VA Healthcare System - Bay Pines
- Comprehensive Wound Healing Center - Clearwater
- Osceola Regional Wound Care Center - Kissimmee
- University of Miami Miller School of Medicine - Miami
- Doctor's Research Network - South Miami
- Robert Snyder, DPM, CWS - Tamarac
California
- Dr. Jagpreet S. Mukker - Fresno
- VA Northern California Health Care System - Mather
- Sutter Roseville Medical Center Wound Care Center - Roseville
- Therapeutics Clinical Research - San Diego
- General Vascular Surgery Group - San Leandro
- Pacific Wound Center - Stockton
Arizona
- Carl T. Hayden VA Medical Center - Phoenix
- HOPE Research Institute - Phoenix
- Southern Arizona VA Health Care System (SAVAHCS) - Tucson
- University of Arizona College of Medicine - Tucson
Alabama
- Coastal Clinical Research, Inc. - Mobile
Connecticut
- North American Center for Limb Preservation - New Haven
District of Columbia
- Providence Hospital - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 537 participants |
| Start Date | 2009-06 |
| Est. Completion | 2011-08 |
| Phase | Phase 3 |
What the finished NCT00909870 record still lists
NCT00909870 is an interventional study that assigns participants to a tested intervention. The registered 537 participants enrollment target is mid-sized for trials with a published cap, above the 230-participant average among 35 other Venous Leg Ulcer trials with a reported enrollment target (133% higher).
The record links to 1 condition, with Venous Leg Ulcer appearing as the primary indexed condition, and to 2 interventions - of which Dermagraft(R) is the first listed.
NCT00909870 names 20 study sites across 6 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT00909870 about?
NCT00909870 is a clinical study titled "Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers". 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 treatmen...
What is the current status of trial NCT00909870?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 537 participants. The study started on 2009-06. Estimated completion is 2011-08.
What conditions does trial NCT00909870 study?
This clinical trial studies the following conditions: Venous Leg Ulcer.
What interventions are being tested in trial NCT00909870?
The interventions under investigation include: Dermagraft(R) (DEVICE), Profore (DEVICE).
Who is sponsoring clinical trial NCT00909870?
This trial is sponsored by Organogenesis, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00909870 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Venous Leg Ulcer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00909870's enrollment target sits among peer trials
537 3rd of 35 higher than 33 of 35 other Venous Leg Ulcer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Venous Leg Ulcer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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