Investigation of Rifampin to Reduce Pedal Amputations for Osteomyelitis in Diabetics

PHASE4Active, not recruitingINTERVENTIONAL
Enrollment

843

Participants

Timeline

Start Date

January 22, 2018

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
OsteomyelitisDiabetesAmputation
Interventions
DRUG

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.

DRUG

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.

Trial Locations (30)

28144

Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC, Salisbury

30033

Atlanta VA Medical and Rehab Center, Decatur, GA, Decatur

33125

Miami VA Healthcare System, Miami, FL, Miami

33612

James A. Haley Veterans' Hospital, Tampa, FL, Tampa

45220

Cincinnati VA Medical Center, Cincinnati, OH, Cincinnati

45428

Dayton VA Medical Center, Dayton, OH, Dayton

55417

Minneapolis VA Health Care System, Minneapolis, MN, Minneapolis

63106

St. Louis VA Medical Center John Cochran Division, St. Louis, MO, St Louis

73104

Oklahoma City VA Medical Center, Oklahoma City, OK, Oklahoma City

77030

Michael E. DeBakey VA Medical Center, Houston, TX, Houston

78229

South Texas Health Care System, San Antonio, TX, San Antonio

85012

Phoenix VA Health Care System, Phoenix, AZ, Phoenix

90073

VA Greater Los Angeles Healthcare System, West Los Angeles, CA, West Los Angeles

90822

VA Long Beach Healthcare System, Long Beach, CA, Long Beach

95655

VA Northern California Health Care System, Mather, CA, Sacramento

92357-1000

VA Loma Linda Healthcare System, Loma Linda, CA, Loma Linda

94304-1207

VA Palo Alto Health Care System, Palo Alto, CA, Palo Alto

80045-7211

Rocky Mountain Regional VA Medical Center, Aurora, CO, Aurora

20422-0001

Washington DC VA Medical Center, Washington, DC, Washington D.C.

33744-0000

Bay Pines VA Healthcare System, Pay Pines, FL, Bay Pines

32608-1135

North Florida/South Georgia Veterans Health System, Gainesville, FL, Gainesville

48105-2303

VA Ann Arbor Healthcare System, Ann Arbor, MI, Ann Arbor

10468-3904

James J. Peters VA Medical Center, Bronx, NY, The Bronx

44106-1702

Louis Stokes VA Medical Center, Cleveland, OH, Cleveland

97207-2964

VA Portland Health Care System, Portland, OR, Portland

37212-2637

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN, Nashville

75216-7167

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX, Dallas

84148-0001

VA Salt Lake City Health Care System, Salt Lake City, UT, Salt Lake City

24153-6404

Salem VA Medical Center, Salem, VA, Salem

53705-2254

William S. Middleton Memorial Veterans Hospital, Madison, WI, Madison

All Listed Sponsors
lead

VA Office of Research and Development

FED