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NCT03012529 · ClinicalTrials.gov registry record · Phase 4
Investigation of Rifampin to Reduce Pedal Amputations for Osteomyelitis in Diabetics
A Phase 4 study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 4
- Development phase
- 843
- Enrollment target
NCT03012529: Completed Phase 4 study, sponsored by VA Office of Research and Development.
NCT03012529 is a Phase 4 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 843 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (63% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03012529, a Phase 4 study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 843 participants
- Enrollment target
Study Summary
The purpose of this research study is to determine if rifampin, an antibiotic (a medicine that treats infections), is effective in treating osteomyelitis (infection of the bone) of the foot in diabetic patients. Despite use of powerful antibiotics prescribed over a long period of time, many diabetic patients remain at a high risk for needing an amputation of part of the foot or lower leg because the osteomyelitis is not cured. Some small research studies have shown that addition of rifampin to other antibiotics is effective in treating osteomyelitis in both diabetics and non-diabetics. However, because few diabetics with osteomyelitis have been studied, there is no definite proof that it is better than the usual treatments for diabetic patients. If this study finds that adding rifampin to the usual antibiotics prescribed for osteomyelitis reduces the risk for amputations, doctors will be able to more effectively treat many Veteran patients with this serious infection. Improving treatment outcomes is an important healthcare goal of the VA.
Primary Outcome
The primary endpoint is amputation-free survival, ending with amputation or death from any cause. Amputation is defined as surgical treatment of osteomyelitis by removal or debridement of necrotic/infected bone (all or part of a bone) from a lower extremity limb or digit on the ipsilateral side of the protocol-treated osteomyelitis. Debridement prior to randomization may include removal of bone. Because this debridement occurs early, prior to exposure to study drug or placebo, removal of bone at
Interventions
- DRUG Rifampin
- DRUG Riboflavin Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 843 participants |
| Start Date | 2018-01-22 |
| Est. Completion | 2025-11-05 |
| Phase | Phase 4 |
What the finished NCT03012529 record still lists
NCT03012529 is an interventional study that assigns participants to a tested intervention. The registered 843 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (63% higher).
The record links to 0 conditions, and to 2 interventions - of which Rifampin is the first listed.
NCT03012529 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03012529 about?
NCT03012529 is a clinical study titled "Investigation of Rifampin to Reduce Pedal Amputations for Osteomyelitis in Diabetics". The purpose of this research study is to determine if rifampin, an antibiotic (a medicine that treats infections), is effective in treating osteomyelitis (infection of the bone) of the foot in diabetic patients. Despite use of powerful antibiotics prescribed over a long period of time, many diabetic...
What is the current status of trial NCT03012529?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 843 participants. The study started on 2018-01-22. Estimated completion is 2025-11-05.
What interventions are being tested in trial NCT03012529?
The interventions under investigation include: Rifampin (DRUG), Riboflavin Placebo (DRUG).
Who is sponsoring clinical trial NCT03012529?
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 NCT03012529's enrollment target sits among peer trials
843 90th of 2000 higher than 1,911 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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