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Intraosseous vs. Intravenous Vancomycin Prophylaxis for Diabetic Foot Amputations: A Randomized Trial

NCT07338773 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-04-22

No results posted yet for this study

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

Conditions

  • Diabetic Foot Disease
  • Diabetic Foot Infection
  • Diabetic Amputation Foot Wound

Interventions

DRUG

Intraosseous Vancomycin

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.

DRUG

Intravenous Vancomycin

A single dose of 500 mg Vancomycin is administered via systemic intravenous infusion for standard prophylactic care.

Sponsors & Collaborators

  • Başakşehir Çam & Sakura City Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-03
Primary Completion
2026-05-04
Completion
2026-06-19

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07338773 on ClinicalTrials.gov