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NCT01143727 · ClinicalTrials.gov registry record · Phase 4
Enzymatic Versus (vs) Autolytic Debridement of Diabetic Foot Ulcers
A Phase 4 study, sponsored by Healthpoint.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
NCT01143727: Completed Phase 4 study, sponsored by Healthpoint.
NCT01143727 is a Phase 4 study that has completed, run by Healthpoint. The registered enrollment target is 20 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01143727, a Phase 4 study, has completed, sponsored by Healthpoint.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
Study Summary
This study compares two standard methods for cleaning the surface of wounds on the feet of patients with diabetes mellitus. The question being asked is whether inflammation of the wound affects the ability of one or both of the methods to work.
Primary Outcome
Weekly wound appearance as assessed by BWAT-m scores. BWAT-m scores used to determine primary efficacy consist of 8 subscales, each grade an aspect of wound status on a 1-5 scale; 1=normal intact skin; 5=least desirable. Total score=8-40. Subscales: Edges, Undermining, Necrotic Tissue Type, Necrotic Tissue Amount, Exudate Type, Exudate Amount, Skin Color Surrounding Wound, and Granulation Tissue.
Interventions
- DRUG Santyl
- DRUG Tegaderm Hydrogel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2010-07 |
| Est. Completion | 2012-10 |
| Phase | Phase 4 |
What the finished NCT01143727 record still lists
NCT01143727 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Santyl is the first listed.
NCT01143727 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01143727 about?
NCT01143727 is a clinical study titled "Enzymatic Versus (vs) Autolytic Debridement of Diabetic Foot Ulcers". This study compares two standard methods for cleaning the surface of wounds on the feet of patients with diabetes mellitus. The question being asked is whether inflammation of the wound affects the ability of one or both of the methods to work.
What is the current status of trial NCT01143727?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2010-07. Estimated completion is 2012-10.
What interventions are being tested in trial NCT01143727?
The interventions under investigation include: Santyl (DRUG), Tegaderm Hydrogel (DRUG).
Who is sponsoring clinical trial NCT01143727?
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 NCT01143727's enrollment target sits among peer trials
20 1753rd of 2000 higher than 167 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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