Intraosseous vs. Intravenous Vancomycin Prophylaxis for Diabetic Foot Amputations: A Randomized Trial
Comparison of the Effects of Intraosseous and Intravenous Vancomycin Prophylaxis on Surgical Site Infections and Clinical Outcomes After Diabetic Foot Amputation: A Randomized Controlled Trial
Başakşehir Çam & Sakura City Hospital
40 participants
Sep 3, 2025
INTERVENTIONAL
Conditions
Summary
he purpose of this study is to compare the effects of two different ways of giving the antibiotic vancomycin to prevent infections in patients undergoing amputation due to diabetic foot infection. Patients with diabetes often have poor blood circulation in their legs, which may prevent standard intravenous (IV) antibiotics from reaching the surgical site in high enough concentrations. This study compares: Intraosseous (IO) Administration: Giving the antibiotic directly into the bone at the amputation site during surgery. Intravenous (IV) Administration: Giving the antibiotic through a standard vein infusion before surgery. The researchers want to find out if the intraosseous method: Reduces the rate of surgical site infections compared to the standard IV method. Causes fewer changes in kidney function (measured by serum creatinine levels). Decreases the need for additional surgeries (reoperations) within 90 days. Patients will be randomly assigned to either the IO or IV group and will be followed for up to 90 days to evaluate their recovery and clinical outcomes
Eligibility
Inclusion Criteria2
- PATIENTS AGED 18 YEARS AND OLDER. DIAGNOSED WITH TYPE 1 OR TYPE 2 DIABETES MELLITUS. SCHEDULED FOR TRANSTIBIAL (BELOW-KNEE) AMPUTATION DUE TO DIABETIC FOOT INFECTION.
- WILLING AND ABLE TO PROVIDE WRITTEN INFORMED CONSENT.
Exclusion Criteria9
- KNOWN ALLERGY OR HYPERSENSITIVITY TO VANCOMYCIN.
- PRE-EXISTING RENAL INSUFFICIENCY (BASELINE SERUM CREATININE > 2.0 MG/DL OR GFR < 30 ML/MIN).
- PREGNANCY OR BREASTFEEDING.
- PREVIOUS SURGICAL INTERVENTION OR AMPUTATION ON THE SAME EXTREMITY.
- BODY MASS INDEX (BMI) OVER 35.
- CONTRAINDICATION TO STANDARD PROPHYLACTIC ANTIBIOTICS.
- INABILITY TO LOCALIZE THE TIBIAL TUBERCLE FOR INTRAOSSEOUS INFUSION.
- IMMUNOCOMPROMISED STATUS (HIV, HEPATITIS C, END-STAGE RENAL DISEASE, DIALYSIS, ACTIVE CHEMOTHERAPY OR RADIOTHERAPY).
- USE OF IMMUNOSUPPRESSIVE DRUGS WITHIN THE LAST 6 MONTHS.
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Interventions
A single dose of 500 mg Vancomycin is administered into the bone marrow (intraosseous route) to achieve high local tissue concentrations at the surgical site.
A single dose of 500 mg Vancomycin is administered via systemic intravenous infusion for standard prophylactic care.
Locations(1)
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NCT07338773