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NCT02111291 · ClinicalTrials.gov registry record · Phase 4
Santyl Applications to Diabetic Foot Ulcers
A Phase 4 study, sponsored by Healthpoint.
- Completed
- Registry status
- Phase 4
- Development phase
- 215
- Enrollment target
NCT02111291: Completed Phase 4 study, sponsored by Healthpoint.
NCT02111291 is a Phase 4 study that has completed, run by Healthpoint. The registered enrollment target is 215 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02111291, a Phase 4 study, has completed, sponsored by Healthpoint.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 215 participants
- Enrollment target
Study Summary
The current trial examines the potential benefits of continuous 12 week treatment with Santyl, measured in terms of wound bed appearance. The visual appearance of granulation tissue will be recorded at each visit for the purpose of examining the relationship between wound bed appearance and progress towards healing. In support of this longer treatment regimen with Santyl, a recent animal study found that application of Santyl for 12 weeks was safe and well tolerated. Therefore, the present study is designed to test the hypothesis that daily treatment of diabetic foot ulcers (DFU) with Santyl for up to 12 weeks will result in more rapid development of granulation tissue than DFU treated with supportive care.
Interventions
- BIOLOGICAL Collagenase SANTYL® Ointment
- BIOLOGICAL Hydrogel (if needed) and foam dressing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 215 participants |
| Start Date | 2014-04 |
| Est. Completion | 2015-12 |
| Phase | Phase 4 |
What the finished NCT02111291 record still lists
NCT02111291 is an interventional study that assigns participants to a tested intervention. The registered 215 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 2 interventions - of which Collagenase SANTYL® Ointment is the first listed.
NCT02111291 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02111291 about?
NCT02111291 is a clinical study titled "Santyl Applications to Diabetic Foot Ulcers". The current trial examines the potential benefits of continuous 12 week treatment with Santyl, measured in terms of wound bed appearance. The visual appearance of granulation tissue will be recorded at each visit for the purpose of examining the relationship between wound bed appearance and progress...
What is the current status of trial NCT02111291?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 215 participants. The study started on 2014-04. Estimated completion is 2015-12.
What interventions are being tested in trial NCT02111291?
The interventions under investigation include: Collagenase SANTYL® Ointment (BIOLOGICAL), Hydrogel (if needed) and foam dressing (BIOLOGICAL).
Who is sponsoring clinical trial NCT02111291?
This trial is sponsored by Healthpoint, which has 25 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02111291's enrollment target sits among peer trials
215 394th of 2000 higher than 1,607 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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