Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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 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.

View on ClinicalTrials.gov ↗

View your shortlist →

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

Venous Leg Ulcer

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

FieldValue
Enrollment Target 537 participants
Start Date 2009-06
Est. Completion 2011-08
Phase Phase 3

Sponsor

Organogenesis

20 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00909870

The ClinicalTrials.gov registry entry for NCT00909870 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 537 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 230-participant average among 35 other Venous Leg Ulcer trials with a reported enrollment target (133% higher). The listed sponsor is Organogenesis, which has 20 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 6 distinct geographic areas - top geographies include 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.

Explore more on PlainTrial

Venous Leg Ulcer

All registered trials for this condition

Alabama

All trials with a study site in Alabama

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.