Trials / Completed
CompletedNCT01891760
Long-Term Follow-Up to the DEVO Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers
A Prospective, Multi-center, Longitudinal, Cohort Study of Dermagraft in Subjects With Venous Leg Ulcers: A Long-term Follow-up to the DEVO-Trial
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 225 (actual)
- Sponsor
- Shire Regenerative Medicine, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
* Observe the long-term (1-year) outcomes of Dermagraft, compared with conventional treatment of four-layer compression bandaging therapy alone, in subjects who completed the ABH-Dermagraft-001-08 study. * Study Hypothesis: N/A (Long-term follow-up study)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Dermagraft | Dermagraft treatment regimen of one application applied topically to the ulcer, weekly, for a maximum of 8 weeks (8 application maximum). |
| DEVICE | Profore | Four-layer compression bandaging therapy. |
Timeline
- Start date
- 2010-05-01
- Primary completion
- 2012-06-01
- Completion
- 2012-06-01
- First posted
- 2013-07-03
- Last updated
- 2013-08-21
Locations
28 sites across 6 countries: United States, Estonia, Germany, Poland, South Africa, United Kingdom
Source: ClinicalTrials.gov record NCT01891760. Inclusion in this directory is not an endorsement.