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COMPLETED
NCT03012529
PHASE4

Investigation of Rifampin to Reduce Pedal Amputations for Osteomyelitis in Diabetics

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

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

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.

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