Trials / Completed
CompletedNCT01181440
Dermagraft(R) for the Treatment of Patients With Diabetic Foot Ulcers
A Prospective, Multicenter, Randomized, Single-Blind Clinical Investigation of Dermagraft(R) in Patients With Plantar Diabetic Foot Ulcers
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 281 (actual)
- Sponsor
- Organogenesis · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study randomly assigns patients with plantar diabetic foot ulcers to receive conventional therapy (debridement, infection control, saline-moistened gauze dressings, and standardized off-weighting) alone or conventional therapy plus Dermagraft(R). Dermagraft is a device containing live human fibroblasts grown on an absorbable polyglactin (Vicryl) mesh. Patients are evaluated weekly until Week 12, then every four weeks until Week 32.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Dermagraft(R) | Weekly application of Dermagraft(R) with conventional care |
| OTHER | Conventional care | Weekly application of conventional care |
Timeline
- Start date
- 1994-09-01
- Primary completion
- 1997-01-01
- Completion
- 1997-01-01
- First posted
- 2010-08-13
- Last updated
- 2018-05-21
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01181440. Inclusion in this directory is not an endorsement.