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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT00909870

Public ClinicalTrials.gov record NCT00909870. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 5:58 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Prospective, Multi-Center, Randomized, Controlled Clinical Investigation of Dermagraft(R) in Subjects With Venous Leg Ulcers DEVO-Trial

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00909870
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Organogenesis
Industry
Enrollment
537 participants

Conditions and interventions

Interventions

Device

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 2009 (Type not available)
Primary completion
May 2011 (Actual)
Completion
Aug 2011 (Actual)
Last update posted
Jun 18, 2018

2009 – 2011

United States locations

U.S. sites
34
U.S. states
19
U.S. cities
31
Facility City State ZIP Site status
Coastal Clinical Research, Inc. Mobile Alabama 36608 —
Carl T. Hayden VA Medical Center Phoenix Arizona 85012 —
HOPE Research Institute Phoenix Arizona 85050 —
Southern Arizona VA Health Care System (SAVAHCS) Tucson Arizona 85723 —
University of Arizona College of Medicine Tucson Arizona 85724 —
Dr. Jagpreet S. Mukker Fresno California 93726 —
VA Northern California Health Care System Mather California 95665 —
Sutter Roseville Medical Center Wound Care Center Roseville California 95661 —
Therapeutics Clinical Research San Diego California 92123 —
General Vascular Surgery Group San Leandro California 94578 —
Pacific Wound Center Stockton California 95204 —
North American Center for Limb Preservation New Haven Connecticut 06515 —
Providence Hospital Washington D.C. District of Columbia 20017 —
Foot & Ankle Associates of Florida Altamonte Springs Florida 32701 —
Bay Pines VA Healthcare System Bay Pines Florida 33744 —
Comprehensive Wound Healing Center Clearwater Florida 33756 —
Osceola Regional Wound Care Center Kissimmee Florida 34741 —
University of Miami Miller School of Medicine Miami Florida 33136 —
Doctor's Research Network South Miami Florida 33143 —
Robert Snyder, DPM, CWS Tamarac Florida 33321 —
Aiyan Diabetes Center Evans Georgia 30809 —
Broadlawns Medical Center Des Moines Iowa 50314-1597 —
Boston Medical Center, Department of Vascular Surgery Boston Massachusetts 02118 —
Beth Israel Deaconess Medical Center Boston Massachusetts 02215 —
Covenant Wound Healing Center Saginaw Michigan 48602 —
Heartland Regional Medical Center Saint Joseph Missouri 64506 —
Advanced Foot & Ankle Center Las Vegas Nevada 89119 —
Overlook Hospital Wound Healing Program Summit New Jersey 07901 —
Stony Brook University Medical Center Stony Brook New York 11794 —
University of North Carolina Division of Vascular Surgery Chapel Hill North Carolina 27599 —
Saint Vincent Health Center Erie Pennsylvania 16544 —
Omega Medical Research Warwick Rhode Island 02886 —
Jackson Madison County General Hospital Jackson Tennessee 38301 —
Dixie Regional Meidcal Center St. George Utah 84770 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 36 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00909870, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 18, 2018 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00909870 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →