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

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

Last updated 2026-07-10

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

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.

DRUG

Intravenous Vancomycin

Participants received a single dose of 500 mg vancomycin intravenously at the same preincision time point before below-knee amputation.

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
2025-08-06
Primary Completion
2026-06-15
Completion
2026-06-21

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