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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03012529
The ClinicalTrials.gov registry entry for NCT03012529 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 843 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Rifampin is the first listed.
NCT03012529 reports 0 study locations.
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.
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