Clinical Research Directory
Browse clinical research sites, groups, and studies.
Intraosseous Versus Intravenous Vancomycin in Below-Knee Amputation for Ischemic Diabetic Foot
Sponsor: Başakşehir Çam & Sakura City Hospital
Summary
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.
Official title: Does Intraosseous Compared With Intravenous Vancomycin Alter Local Exposure, Systemic Safety, and Early Outcomes in Patients With Ischemic Diabetic Foot Undergoing Below-knee Amputation? A Randomized Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2025-08-06
Completion Date
2026-06-21
Last Updated
2026-07-10
Healthy Volunteers
No
Interventions
Intraosseous Vancomycin
Participants received a single dose of 500 mg vancomycin diluted in 100 mL of 0.9% normal saline into the proximal tibial metaphysis using a sterile intraosseous vascular access system immediately before skin incision.
Intravenous Vancomycin
Participants received a single dose of 500 mg vancomycin intravenously at the same preincision time point before below-knee amputation.
Locations (1)
Basaksehir Cam ve Sakura City Hospital
Istanbul, Istanbul, Turkey (Türkiye)