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NCT01408277 · ClinicalTrials.gov registry record · Phase 4
Using Santyl on Diabetic Foot Ulcers
A Phase 4 study, sponsored by Healthpoint.
- Completed
- Registry status
- Phase 4
- Development phase
- 55
- Enrollment target
NCT01408277: Completed Phase 4 study, sponsored by Healthpoint.
NCT01408277 is a Phase 4 study that has completed, run by Healthpoint. The registered enrollment target is 55 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01408277, a Phase 4 study, has completed, sponsored by Healthpoint.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 55 participants
- Enrollment target
Study Summary
Subjects enrolled in this study will either use Santyl daily or follow standard care procedures for up to 6 weeks for their diabetic foot wound. After 6 weeks of treatment, the subjects will continue into the follow-up phase for an additional 6 weeks. Study doctors will look at the wound in the office each week (up to 12 weeks) to see if the wound is healing. Depending on a number of factors at each office visit, the study doctors may also use a procedure called sharp debridement to remove dead skin from the wound. This study will test the hypothesis that daily treatment of diabetic foot wounds with Santyl will result in more rapid healing, healthier wounds, and fewer required sharp debridements over the study period than for diabetic foot wounds treated in other ways.
Primary Outcome
Wound area was measured using the ARANZ Silhouette digital wound imaging and measurement device. The average percent (%) of change from baseline of the target wound area at the end of the 6-week treatment period and the end of the entire 12-week study period respectively, was calculated using a two-way ANCOVA model.
Interventions
- PROCEDURE Control
- BIOLOGICAL Santyl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2011-08 |
| Est. Completion | 2013-03 |
| Phase | Phase 4 |
What the finished NCT01408277 record still lists
NCT01408277 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Control is the first listed.
NCT01408277 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01408277 about?
NCT01408277 is a clinical study titled "Using Santyl on Diabetic Foot Ulcers". Subjects enrolled in this study will either use Santyl daily or follow standard care procedures for up to 6 weeks for their diabetic foot wound. After 6 weeks of treatment, the subjects will continue into the follow-up phase for an additional 6 weeks. Study doctors will look at the wound in the offi...
What is the current status of trial NCT01408277?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 55 participants. The study started on 2011-08. Estimated completion is 2013-03.
What interventions are being tested in trial NCT01408277?
The interventions under investigation include: Control (PROCEDURE), Santyl (BIOLOGICAL).
Who is sponsoring clinical trial NCT01408277?
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 NCT01408277's enrollment target sits among peer trials
55 1218th of 2000 higher than 778 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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