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NCT02581488 · ClinicalTrials.gov registry record · Phase 4
Use of Santyl in Diabetic Foot Ulcers
A Phase 4 study, sponsored by Smith & Nephew.
- Completed
- Registry status
- Phase 4
- Development phase
- 102
- Enrollment target
NCT02581488: Completed Phase 4 study, sponsored by Smith & Nephew.
NCT02581488 is a Phase 4 study that has completed, run by Smith & Nephew. The registered enrollment target is 102 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02581488, a Phase 4 study, has completed, sponsored by Smith & Nephew.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 102 participants
- Enrollment target
Study Summary
This study is designed to test the hypothesis that daily treatment of diabetic foot ulcers with an enzymatic debriding agent, SANTYL, for up to 6 weeks will result in more rapid decrease in ulcer area than diabetic foot ulcers treated with a topical treatment containing silver. After meeting study criteria, participants will be randomly assigned to apply SANTYL or a topical treatment containing silver to their to foot ulcer for up to 6 weeks. At the end of 6 weeks, participants will be followed for an additional 4 weeks to examine the outcome of the study treatment.
Primary Outcome
Ulcer area was measured using the ARANZ Silhouette digital imaging and measurement device.
Interventions
- BIOLOGICAL Santyl
- OTHER Product containing silver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2015-10 |
| Est. Completion | 2017-01-12 |
| Phase | Phase 4 |
What the finished NCT02581488 record still lists
NCT02581488 is an interventional study that assigns participants to a tested intervention. The registered 102 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 (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Santyl is the first listed.
NCT02581488 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02581488 about?
NCT02581488 is a clinical study titled "Use of Santyl in Diabetic Foot Ulcers". This study is designed to test the hypothesis that daily treatment of diabetic foot ulcers with an enzymatic debriding agent, SANTYL, for up to 6 weeks will result in more rapid decrease in ulcer area than diabetic foot ulcers treated with a topical treatment containing silver. After meeting study c...
What is the current status of trial NCT02581488?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 102 participants. The study started on 2015-10. Estimated completion is 2017-01-12.
What interventions are being tested in trial NCT02581488?
The interventions under investigation include: Santyl (BIOLOGICAL), Product containing silver (OTHER).
Who is sponsoring clinical trial NCT02581488?
This trial is sponsored by Smith & Nephew, which has 72 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02581488's enrollment target sits among peer trials
102 764th of 2000 higher than 1,235 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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