Trials / Terminated
TerminatedNCT00387101
Efficacy and Safety Study in the Treatment of Chronic Diabetic Foot Ulcers
Pivotal Study to Evaluate the Efficacy and Safety of Dermal-Living Skin Replacement (Dermal-LSR) in the Treatment of Chronic Diabetic Foot Ulcers
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 288 (estimated)
- Sponsor
- ApoPharma · Industry
- Sex
- All
- Age
- 18 Years – 84 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the safety and efficacy of Dermal-LSR plus Standard of Care (SOC) for the treatment of diabetic foot ulcers (DFU)in comparison to the treatment to SOC alone.
Detailed description
The study is a pivotal, prospective, randomized, controlled, open-label, multi-center study that will evaluate the effectiveness and safety of topically applied Dermal-LSR in chronic DFUs.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Dermal - Living Skin Replacement (Dermal - LSR) |
Timeline
- Start date
- 2006-02-01
- Primary completion
- 2007-09-01
- Completion
- 2008-04-01
- First posted
- 2006-10-12
- Last updated
- 2008-05-02
Locations
12 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00387101. Inclusion in this directory is not an endorsement.