CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 537 enrolled
Drug / intervention
Dermagraft(R) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00909870
NCT00909870Phase 3Completed
CompareCT.gov

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

Organogenesis·interventional·Posted May 29, 2009·Updated Jun 18, 2018

In Brief

A Phase 3 clinical trial evaluating Dermagraft(R) and Profore for Venous Leg Ulcer. Completed, enrolled 537 participants across 70 sites in 8 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVenous Leg Ulcer
CountriesAustria, Estonia, Germany, Poland, South Africa, Sweden, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 29, 2009
Enrollment StartJun 1, 2009
Primary CompletionMay 1, 2011
Study CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 17.1 years ago

Interventions

Dermagraft(R)device

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

Proforedevice

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