Trials / Completed
CompletedNCT01181453
Pivotal Trial of Dermagraft(R) to Treat Diabetic Foot Ulcers
A Prospective, Multicenter, Randomized, Single-Blind, Phase III, Clinical Investigation of Dermagraft(R) in Patients With Plantar Diabetic Foot Ulcers
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 314 (actual)
- Sponsor
- Organogenesis · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study randomly assigns patients with diabetic foot ulcers to receive standard therapy (surgical debridement, saline-moistened gauze and offloading) alone or standard therapy 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 12-week treatment period is complete.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Dermagraft | Weekly application of Dermagraft(R) with standard care |
| OTHER | Comparator | Weekly application of standard care |
Timeline
- Start date
- 1998-12-01
- Primary completion
- 2000-03-01
- Completion
- 2000-03-01
- First posted
- 2010-08-13
- Last updated
- 2018-05-21
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01181453. Inclusion in this directory is not an endorsement.