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NCT01849965 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Study Evaluating Efficacy and Safety of DSC127 Compared With Vehicle and With Standard-of-care in Diabetic Foot Ulcers
A Phase 3 study, sponsored by Integra LifeSciences Corporation.
- Terminated
- Registry status
- Phase 3
- Development phase
- 396
- Enrollment target
NCT01849965 is a Phase 3 study that was terminated before completion, run by Integra LifeSciences Corporation. The registered enrollment target is 396 participants.
The verdict
NCT01849965, a Phase 3 study, was terminated before completion, sponsored by Integra LifeSciences Corporation.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 396 participants
- Enrollment target
Study Summary
To determine if aclerastide (DSC127) is effective in increasing incidence of complete wound closure up to 10 weeks confirmed 2 weeks later, compared with vehicle (gel without active ingredient) and compared with a standard-of-care gel, in subjects with diabetes mellitus (DM) who have chronic Wagner Grade 1 or 2 diabetic foot ulcers, 0.75 - 6cm2 in size.
Interventions
- DRUG DSC127
- DRUG placebo vehicle gel
- DRUG Standard of Care gel, Aquasite
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 396 participants |
| Start Date | 2013-04 |
| Est. Completion | 2015-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01849965
The ClinicalTrials.gov registry entry for NCT01849965 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 396 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 3 interventions - of which DSC127 is the first listed.
NCT01849965 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01849965 about?
NCT01849965 is a clinical study titled "Phase 3 Study Evaluating Efficacy and Safety of DSC127 Compared With Vehicle and With Standard-of-care in Diabetic Foot Ulcers". To determine if aclerastide (DSC127) is effective in increasing incidence of complete wound closure up to 10 weeks confirmed 2 weeks later, compared with vehicle (gel without active ingredient) and compared with a standard-of-care gel, in subjects with diabetes mellitus (DM) who have chronic Wagner ...
What is the current status of trial NCT01849965?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 396 participants. The study started on 2013-04. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01849965?
The interventions under investigation include: DSC127 (DRUG), placebo vehicle gel (DRUG), Standard of Care gel, Aquasite (DRUG).
Who is sponsoring clinical trial NCT01849965?
This trial is sponsored by Integra LifeSciences Corporation, which has 60 total clinical trials registered on ClinicalTrials.gov.
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