drugset / Trial / NCT03012529

Investigation of Rifampin to Reduce Pedal Amputations for Osteomyelitis in Diabetics

NCT03012529

Phase 4 Completed 843 enrolled VA Office of Research and Development
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2018-01-22
Primary completion
2025-11-05
Completion
2025-11-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Rifampin Small molecule 600 mg Oral