Intraosseous Versus Intravenous Vancomycin in Below-Knee Amputation for Ischemic Diabetic Foot

This randomized clinical trial compared two routes of vancomycin administration in patients undergoing below-knee amputation for ischemic diabetic foot infection. Patients with diabetic foot infection and impaired lower-extremity circulation may have reduced delivery of intravenously administered antibiotics to the amputation stump. Intraosseous administration may increase local antibiotic exposure at the surgical site while reducing systemic exposure. Participants were randomly assigned to receive either intraosseous vancomycin or intravenous vancomycin before skin incision. The study evaluated vancomycin concentrations in amputation stump subcutaneous tissue, simultaneous serum vancomycin concentrations, tissue-to-serum concentration ratios, inflammatory marker trajectories, early wound outcomes, pain scores, drain output, reintervention, mortality, renal safety, and systemic adverse events through postoperative follow-up.

NCT Number	NCT07338773
Lead Sponsor	Başakşehir Çam & Sakura City Hospital
Conditions	Diabetic Foot Disease, Diabetic Foot Infection, Diabetic Amputation Foot Wound
Enrollment	40 participants
Start Date	2025-08-06
Primary Completion	2026-06-15 (estimated)
Study Completion	2026-06-21 (estimated)
Updated on ClinicalTrials.gov	2026-07-10