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Could a common antibiotic save diabetic feet from amputation?

NCT ID NCT03012529

Disease control Sponsor: VA Office of Research and Development Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether adding the antibiotic rifampin to standard treatment helps prevent amputations in diabetic patients with foot bone infections. Over 800 veterans participated, receiving either rifampin or a placebo for six weeks. The goal was to see if rifampin improves amputation-free survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Rifampin (an antibiotic)
What this could lead to
If it works, adding rifampin to usual antibiotics could lower the risk of foot or leg amputation in diabetic patients with bone infection.
What could go wrong
This is a completed Phase 4 trial, but results may not apply to all patients. Rifampin can cause side effects like stomach upset and urine discoloration, and may not improve outcomes for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

843 people

The number who actually took part.

Started

Jan 2018

Finished

Nov 2025

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 89 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 18 and 89 years 2. Diagnosis of diabetes mellitus, either by: 1) use of oral hypoglycemic agents or insulin at the time of enrollment; 2) a hemoglobin A1c (HgA1c) level within the past 90 days \> 6.5; or 3) a medical record diagnosis of diabetes mellitus by a clinician on two or more occasions in the previous 10 years 3. Definite or probable osteomyelitis in the diabetic foot, as defined by the International Working Group on the Diabetic Foot (Table 1). Criteria must be present at some point within 90 days prior to enrollment. 4. All planned debridement has been completed prior to randomization. 5. A course of backbone antimicrobial therapy has been selected. Exclusion Criteria: 1. Patient unable to receive enteral medication. 2. Patient is allergic to or intolerant of rifampin. 3. Patient is taking a drug that has interactions with rifampin that would require either stoppage, substitution or an empiric dose modification that may place the patient at medical risk. 4. Within 30 days of enrollment, patient is taking immunosuppressive medications to prevent rejection of an organ transplant or is receiving chemotherapy for cancer or molecularly targeted therapies for cancer. 5. Patient is receiving antiretroviral therapy for HIV or antiviral medication for Hepatitis C. 6. Patient is participating in another interventional clinical trial for which a waiver of dual enrollment with CSP#2001 has not been obtained. 7. Patient has an ALT \> 3 times the upper limit of normal for the site laboratory, or total bilirubin \> 2.5 times the upper limit of normal for the site laboratory\*,\*\*\*; INR \> 1.5, OR patient has Child-Pugh Class C Cirrhosis. 8. Patient has a baseline white blood cell count (WBC) \<2000 cells/mm3\*\*\* OR absolute neutrophil count (ANC) \<1000 cells/mm3\*\*\* OR platelet count \<50,000 cells/mm3\*\*,\*\*\* OR hemoglobin \<8.0 g/dL.\*\*,\*\*\*. 9. Women of child-bearing potential (those with menses within the last year) with a positive serum pregnancy test. 10. Patient is believed unlikely to be able to complete the trial due to medical conditions. 11. Patient is believed unlikely to complete the trial due to neurologic and psycho-behavioral disorders such as active substance abuse or dependence, disabling dementias or psychoses. 12. Patient refuses or is clinically unable to undergo the recommended level of debridement. 13. Indwelling hardware present in the foot, at the site of the index osteomyelitis. 14. Treatment with antibacterial agents for infection at another site, where the duration of treatment is anticipated to be greater than 14 days. 15. Patient is receiving therapy for COVID-19 that interacts with rifampin. * Patients with total bilirubin \> 2 times the ULN who have Gilbert's Disease or any other inherited disease affecting bilirubin metabolism without meeting other exclusionary criteria, may be considered for inclusion in the study. * Patients with platelet count \<50,000 cells/mm3 due only to hypersplenism and meeting no other exclusionary criteria may be considered for inclusion in the study. * If multiple laboratory values are available, the most recent value will be applied for eligibility.

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Conditions

The condition(s) this trial relates to.

diabetes mellitus osteomyelitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Amputation Diabetes Osteomyelitis

Contacts and locations

Locations

  • Atlanta VA Medical and Rehab Center, Decatur, GA

    Decatur, Georgia, 30033, United States

  • Bay Pines VA Healthcare System, Pay Pines, FL

    Bay Pines, Florida, 33744-0000, United States

  • Cincinnati VA Medical Center, Cincinnati, OH

    Cincinnati, Ohio, 45220, United States

  • Dayton VA Medical Center, Dayton, OH

    Dayton, Ohio, 45428, United States

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

    Tampa, Florida, 33612, United States

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

    The Bronx, New York, 10468-3904, United States

  • Louis Stokes VA Medical Center, Cleveland, OH

    Cleveland, Ohio, 44106-1702, United States

  • Miami VA Healthcare System, Miami, FL

    Miami, Florida, 33125, United States

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

    Houston, Texas, 77030, United States

  • Minneapolis VA Health Care System, Minneapolis, MN

    Minneapolis, Minnesota, 55417, United States

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

    Gainesville, Florida, 32608-1135, United States

  • Oklahoma City VA Medical Center, Oklahoma City, OK

    Oklahoma City, Oklahoma, 73104, United States

  • Phoenix VA Health Care System, Phoenix, AZ

    Phoenix, Arizona, 85012, United States

  • Rocky Mountain Regional VA Medical Center, Aurora, CO

    Aurora, Colorado, 80045-7211, United States

  • Salem VA Medical Center, Salem, VA

    Salem, Virginia, 24153-6404, United States

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

    Salisbury, North Carolina, 28144, United States

  • South Texas Health Care System, San Antonio, TX

    San Antonio, Texas, 78229, United States

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

    St Louis, Missouri, 63106, United States

  • Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

    Nashville, Tennessee, 37212-2637, United States

  • VA Ann Arbor Healthcare System, Ann Arbor, MI

    Ann Arbor, Michigan, 48105-2303, United States

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

    West Los Angeles, California, 90073, United States

  • VA Loma Linda Healthcare System, Loma Linda, CA

    Loma Linda, California, 92357-1000, United States

  • VA Long Beach Healthcare System, Long Beach, CA

    Long Beach, California, 90822, United States

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

    Dallas, Texas, 75216-7167, United States

  • VA Northern California Health Care System, Mather, CA

    Sacramento, California, 95655, United States

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

    Palo Alto, California, 94304-1207, United States

  • VA Portland Health Care System, Portland, OR

    Portland, Oregon, 97207-2964, United States

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

    Salt Lake City, Utah, 84148-0001, United States

  • Washington DC VA Medical Center, Washington, DC

    Washington D.C., District of Columbia, 20422-0001, United States

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

    Madison, Wisconsin, 53705-2254, United States

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