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NCT03503370 · ClinicalTrials.gov registry record · Phase 2
Preventing Diabetic Foot Ulcers Through Cleaner Feet
A Phase 2 study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 175
- Enrollment target
NCT03503370: Completed Phase 2 study, sponsored by VA Office of Research and Development.
NCT03503370 is a Phase 2 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 175 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03503370, a Phase 2 study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 175 participants
- Enrollment target
Study Summary
Foot complications are among the most serious and costly complications of diabetes. People with diabetes have a 10-fold increased risk for a leg or foot amputation compared to those that do not have diabetes. Amputation of all or part of foot is usually preceded by a foot ulcer, which became infected. This is a clinical trial to test the effectiveness of a topical antiseptic, chlorhexidine, for daily foot cleaning on the occurrence of diabetic foot ulcers in Veterans at high risk of a diabetic foot ulcer.
Primary Outcome
Time in days to new foot complication (analyzed with the use of unadjusted Cox proportional-hazard models to identify time to new foot complication; the results we are reporting are number of participants who developed a new foot complication in the 12 months post randomization). A new foot complication is defined as either 1) a new chronic (present 28 days from initial diagnosis) foot ulcer or wound or 2) a moderate or severe foot infection (as defined by IDSA Diabetic Foot Infection Severity c
Interventions
- DRUG Placebo
- DRUG Chlorhexidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 175 participants |
| Start Date | 2019-01-02 |
| Est. Completion | 2023-01-06 |
| Phase | Phase 2 |
What the finished NCT03503370 record still lists
NCT03503370 is an interventional study that assigns participants to a tested intervention. The registered 175 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03503370 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03503370 about?
NCT03503370 is a clinical study titled "Preventing Diabetic Foot Ulcers Through Cleaner Feet". Foot complications are among the most serious and costly complications of diabetes. People with diabetes have a 10-fold increased risk for a leg or foot amputation compared to those that do not have diabetes. Amputation of all or part of foot is usually preceded by a foot ulcer, which became infecte...
What is the current status of trial NCT03503370?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 175 participants. The study started on 2019-01-02. Estimated completion is 2023-01-06.
What interventions are being tested in trial NCT03503370?
The interventions under investigation include: Placebo (DRUG), Chlorhexidine (DRUG).
Who is sponsoring clinical trial NCT03503370?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03503370's enrollment target sits among peer trials
175 396th of 2000 higher than 1,605 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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