Actively Recruiting
Intraosseous vs. Intravenous Vancomycin Prophylaxis for Diabetic Foot Amputations: A Randomized Trial
Led by Başakşehir Çam & Sakura City Hospital · Updated on 2026-04-22
40
Participants Needed
1
Research Sites
41 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Intraosseous vs. Intravenous Vancomycin Prophylaxis for Diabetic Foot Amputations: A Randomized Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
Basaksehir Cam ve Sakura City Hospital
Istanbul, Istanbul, Turkey (Türkiye), 34010
Actively Recruiting
Research Team
L
lezgin mert
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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