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NCT03282981 · ClinicalTrials.gov registry record · Phase 3
Beta Adrenergic Antagonist for the Healing of Chronic DFU
A Phase 3 study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 48
- Enrollment target
NCT03282981: Completed Phase 3 study, sponsored by VA Office of Research and Development.
NCT03282981 is a Phase 3 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 48 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03282981, a Phase 3 study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 48 participants
- Enrollment target
Study Summary
One in four Veterans is affected by diabetes and will develop a diabetic foot ulcer. Diabetic ulcers are very challenging to manage and are the most common cause of leg amputation. Many advanced treatments are expensive and difficult to use in the clinic or at home. Those newer therapies have shown little success in healing diabetic foot wounds. The investigators' laboratory and animal work has suggested that a safe medication, currently used as an eye drop for treatment of glaucoma, can heal these ulcers. The investigators are proposing to test this drop (timolol) directly on the surface of the foot ulcer to see if can improve healing faster than the current standard of care. To do this, the investigators propose a "randomized controlled trial" with two groups of patients with diabetic foot ulcers: one will receive standard of care with timolol while the other will receive standard of care with a gel (hydrogel, as placebo medicine).
Primary Outcome
Complete wound closure will be assessed by Investigators and is defined as 100% epithelialization of the wound site ("skin re-epithelialization without drainage or dressing requirements by Week 12). The primary outcome was the proportion of patients with complete wound healing by the end of the treatment phase, evaluated using Fisher's exact test.
Interventions
- DRUG Timolol
- DRUG Non biologically active gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2018-07-24 |
| Est. Completion | 2024-04-30 |
| Phase | Phase 3 |
What the finished NCT03282981 record still lists
NCT03282981 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Timolol is the first listed.
NCT03282981 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03282981 about?
NCT03282981 is a clinical study titled "Beta Adrenergic Antagonist for the Healing of Chronic DFU". One in four Veterans is affected by diabetes and will develop a diabetic foot ulcer. Diabetic ulcers are very challenging to manage and are the most common cause of leg amputation. Many advanced treatments are expensive and difficult to use in the clinic or at home. Those newer therapies have shown ...
What is the current status of trial NCT03282981?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 48 participants. The study started on 2018-07-24. Estimated completion is 2024-04-30.
What interventions are being tested in trial NCT03282981?
The interventions under investigation include: Timolol (DRUG), Non biologically active gel (DRUG).
Who is sponsoring clinical trial NCT03282981?
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 NCT03282981's enrollment target sits among peer trials
48 1862nd of 2000 higher than 134 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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