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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: Clinical Trial Phase 3 study, sponsored by Integra LifeSciences Corporation.
NCT01830348 is a Phase 3 study that was terminated before completion, run by Integra LifeSciences Corporation. The registered enrollment target is 266 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Primary endpoint of complete closure is assessed by the Principal Investigator at the site; ulcer measurements are calculated through tracings submitted to the Canfield system and photographs are collected as confirmation of closure via the Canfield system.
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 |
Why NCT01830348 stopped before completion
NCT01830348 is an interventional study that assigns participants to a tested intervention. The registered 266 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 (66% lower).
The record links to 0 conditions, and to 2 interventions - of which DSC127 is the first listed.
NCT01830348 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01830348's enrollment target sits among peer trials
266 1222nd of 2000 higher than 778 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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