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NCT01840085 · ClinicalTrials.gov registry record · Phase 3
Open-Label Study in Diabetic Foot Ulcers (DFU), to Evaluate Safety of 0.03% DSC127 Topical Gel in Chronic Use
A Phase 3 study, sponsored by Integra LifeSciences Corporation.
- Terminated
- Registry status
- Phase 3
- Development phase
- 261
- Enrollment target
NCT01840085: Clinical Trial Phase 3 study, sponsored by Integra LifeSciences Corporation.
NCT01840085 is a Phase 3 study that was terminated before completion, run by Integra LifeSciences Corporation. The registered enrollment target is 261 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
NCT01840085, a Phase 3 study, was terminated before completion, sponsored by Integra LifeSciences Corporation.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 261 participants
- Enrollment target
Study Summary
To evaluate the safety of topical 0.03% DSC127 Gel when used for one or more continuous treatment periods on a chronic Wagner Grade 1 or 2 foot ulcer(target ulcer) or multiple ulcers in diabetic subjects. The maximum duration of any treatment period is 24 weeks.
Interventions
- DRUG 0.03% DSC127 topical gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 261 participants |
| Start Date | 2015-12 |
| Est. Completion | 2015-12 |
| Phase | Phase 3 |
Why NCT01840085 stopped before completion
NCT01840085 is an interventional study that assigns participants to a tested intervention. The registered 261 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 1 intervention - of which 0.03% DSC127 topical gel is the first listed.
NCT01840085 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01840085 about?
NCT01840085 is a clinical study titled "Open-Label Study in Diabetic Foot Ulcers (DFU), to Evaluate Safety of 0.03% DSC127 Topical Gel in Chronic Use". To evaluate the safety of topical 0.03% DSC127 Gel when used for one or more continuous treatment periods on a chronic Wagner Grade 1 or 2 foot ulcer(target ulcer) or multiple ulcers in diabetic subjects. The maximum duration of any treatment period is 24 weeks.
What is the current status of trial NCT01840085?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 261 participants. The study started on 2015-12. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01840085?
The interventions under investigation include: 0.03% DSC127 topical gel (DRUG).
Who is sponsoring clinical trial NCT01840085?
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 NCT01840085's enrollment target sits among peer trials
261 1228th of 2000 higher than 771 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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