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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: Clinical Trial Phase 3 study, sponsored by Integra LifeSciences Corporation.
NCT01849965 is a Phase 3 study that was terminated before completion, run by Integra LifeSciences Corporation. The registered enrollment target is 396 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Primary endpoint of complete closure is assessed by the Principal Investigator at the site; ulcer measurements are calculated via tracings submitted to the Canfield system, and photographs are collected as confirmation of closure via the Canfield system. Assessment of aclerastide (DSC127) vs vehicle control.
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 |
Why NCT01849965 stopped before completion
NCT01849965 is an interventional study that assigns participants to a tested intervention. The registered 396 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% lower).
The record links to 0 conditions, and to 3 interventions - of which DSC127 is the first listed.
NCT01849965 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01849965's enrollment target sits among peer trials
396 964th of 2000 higher than 1,036 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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