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NCT01830348 · ClinicalTrials.gov registry record · Phase 3
Phase III Study to Evaluate Efficacy and Safety of DSC127 in Diabetic Foot Ulcers
A Phase 3 study, sponsored by Integra LifeSciences Corporation.
- Terminated
- Registry status
- Phase 3
- Development phase
- 266
- Enrollment target
NCT01830348 is a Phase 3 study that was terminated before completion, run by Integra LifeSciences Corporation. The registered enrollment target is 266 participants.
The verdict
NCT01830348, a Phase 3 study, was terminated before completion, sponsored by Integra LifeSciences Corporation.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 266 participants
- Enrollment target
Study Summary
The purpose of the study is to determine if DSC127 is effective in increasing incidence of complete wound closure at 10 weeks confirmed at a visit 2 weeks later when compared to the vehicle (gel without active ingredient) in subjects with diabetes mellitus (DM) who have chronic Wagner Grade 1 or 2 plantar neuropathic foot ulcers, 0.75 - 6 cm2 in size.
Interventions
- DRUG DSC127
- DRUG placebo vehicle gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 266 participants |
| Start Date | 2013-02 |
| Est. Completion | 2015-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01830348
The ClinicalTrials.gov registry entry for NCT01830348 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 266 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Integra LifeSciences Corporation, which has 60 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which DSC127 is the first listed.
NCT01830348 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01830348 about?
NCT01830348 is a clinical study titled "Phase III Study to Evaluate Efficacy and Safety of DSC127 in Diabetic Foot Ulcers". The purpose of the study is to determine if DSC127 is effective in increasing incidence of complete wound closure at 10 weeks confirmed at a visit 2 weeks later when compared to the vehicle (gel without active ingredient) in subjects with diabetes mellitus (DM) who have chronic Wagner Grade 1 or 2 p...
What is the current status of trial NCT01830348?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 266 participants. The study started on 2013-02. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01830348?
The interventions under investigation include: DSC127 (DRUG), placebo vehicle gel (DRUG).
Who is sponsoring clinical trial NCT01830348?
This trial is sponsored by Integra LifeSciences Corporation, which has 60 total clinical trials registered on ClinicalTrials.gov.
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