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Investigation of Rifampin to Reduce Pedal Amputations for Osteomyelitis in Diabetics
Sponsor: VA Office of Research and Development
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.
Official title: CSP #2001 - Investigation of Rifampin to Reduce Pedal Amputations for Osteomyelitis in Diabetics (VA Intrepid)
Key Details
Gender
All
Age Range
18 Years - 89 Years
Study Type
INTERVENTIONAL
Enrollment
843
Start Date
2018-01-22
Completion Date
2025-11-05
Last Updated
2026-04-20
Healthy Volunteers
No
Conditions
Interventions
Rifampin
Subjects who are randomly assigned to adjunctive rifampin will receive a 600 mg oral daily dose targeted for a six-week period. If a subject experiences gastrointestinal intolerance on once daily dosing, the study drug may be administered as rifampin 300 mg twice a day.
Riboflavin Placebo
A placebo capsule will be administered daily to match frequency and duration of rifampin interventional drug. For the purpose of mimicking urine discoloration when taking rifampin, riboflavin will be added to the placebo to produce a urine discoloration effect.
Locations (30)
Phoenix VA Health Care System, Phoenix, AZ
Phoenix, Arizona, United States
VA Loma Linda Healthcare System, Loma Linda, CA
Loma Linda, California, United States
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, United States
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States
VA Northern California Health Care System, Mather, CA
Sacramento, California, United States
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, United States
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, United States
Washington DC VA Medical Center, Washington, DC
Washington D.C., District of Columbia, United States
Bay Pines VA Healthcare System, Pay Pines, FL
Bay Pines, Florida, United States
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, United States
Miami VA Healthcare System, Miami, FL
Miami, Florida, United States
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, United States
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States
St. Louis VA Medical Center John Cochran Division, St. Louis, MO
St Louis, Missouri, United States
James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, United States
Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC
Salisbury, North Carolina, United States
Cincinnati VA Medical Center, Cincinnati, OH
Cincinnati, Ohio, United States
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, United States
Dayton VA Medical Center, Dayton, OH
Dayton, Ohio, United States
Oklahoma City VA Medical Center, Oklahoma City, OK
Oklahoma City, Oklahoma, United States
VA Portland Health Care System, Portland, OR
Portland, Oregon, United States
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, United States
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, United States
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States
South Texas Health Care System, San Antonio, TX
San Antonio, Texas, United States
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, United States
Salem VA Medical Center, Salem, VA
Salem, Virginia, United States
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, United States