Intraosseous versus intravenous vancomycin to prevent infection after below-knee amputation
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
This trial will test whether giving vancomycin directly into the bone at the amputation site prevents surgical infections better than the usual IV dose for adults with diabetes undergoing below-knee amputation.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Başakşehir Çam & Sakura City Hospital Government |
| Drugs / interventions | CHEMOTHERAPY |
| Locations | 1 site (Istanbul, Istanbul) |
| Trial ID | NCT07338773 on ClinicalTrials.gov |
What this trial studies
This randomized, controlled trial assigns adults with diabetes undergoing transtibial (below-knee) amputation to receive 500 mg vancomycin either intraosseously at the amputation site during surgery or intravenously before surgery. Researchers will compare rates of surgical site infection, changes in serum creatinine, and the need for reoperation within 90 days. Key exclusions include significant baseline renal impairment, BMI over 35, prior surgery on the same limb, and immunocompromised status. Outcomes will be measured using clinical infection criteria, laboratory creatinine values, and surgical records during scheduled follow-up.
Who should consider this trial
Good fit: Adults (≥18) with type 1 or type 2 diabetes scheduled for transtibial (below-knee) amputation for diabetic foot infection who can provide informed consent and do not have severe renal failure are the intended candidates.
Not a fit: Patients with baseline serum creatinine >2.0 mg/dL or GFR <30 mL/min, BMI >35, prior surgery on the same extremity, pregnancy or breastfeeding, immunocompromised status, or inability to localize the tibial tubercle for intraosseous infusion are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, intraosseous vancomycin could lower surgical-site infection rates, reduce systemic kidney exposure, and decrease the need for repeat operations.
How similar studies have performed: Prior studies in total knee arthroplasty have shown higher local antibiotic tissue concentrations with intraosseous delivery, but using IO vancomycin for diabetic foot amputations is relatively novel and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Criteria: 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.
Where this trial is running
Istanbul, Istanbul
- Basaksehir Cam ve Sakura City Hospital — Istanbul, Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: lezgin mert
- Email: lezginmert@gmail.com
- Phone: +905056003904
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.