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

April 21, 2026 updated by: Lezgin Mert, Başakşehir Çam & Sakura City Hospital

Comparison of the Effects of Intraosseous and Intravenous Vancomycin Prophylaxis on Surgical Site Infections and Clinical Outcomes After Diabetic Foot Amputation: A Randomized Controlled Trial

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

DETAILED DESCRIPTION THE SURGICAL MANAGEMENT OF DIABETIC FOOT INFECTIONS IS OFTEN COMPLICATED BY PERIPHERAL VASCULAR DISEASE, WHICH SIGNIFICANTLY IMPAIRS THE DELIVERY OF SYSTEMIC PROPHYLACTIC ANTIBIOTICS TO THE INFECTED OR ISCHEMIC EXTREMITY. THIS PROSPECTIVE, RANDOMIZED, CONTROLLED STUDY INVESTIGATES WHETHER INTRAOSSEOUS (IO) ADMINISTRATION OF VANCOMYCIN PROVIDES A SUPERIOR CLINICAL OUTCOME BY DELIVERING HIGHER LOCAL TISSUE CONCENTRATIONS COMPARED TO TRADITIONAL INTRAVENOUS (IV) ADMINISTRATION.

STUDY RATIONALE AND HYPOTHESIS: PREVIOUS STUDIES IN TOTAL KNEE ARTHROPLASTY HAVE SHOWN THAT IO ADMINISTRATION INCREASES LOCAL ANTIBIOTIC TISSUE CONCENTRATION WHILE REDUCING SYSTEMIC LEVELS. DUE TO PERIPHERAL VASCULAR DISEASE IN DIABETIC FOOT PATIENTS, WE BELIEVE THAT SYSTEMICALLY ADMINISTERED VANCOMYCIN (IV) WILL REACH LOWER CONCENTRATIONS AT THE SURGICAL SITE. WE HYPOTHESIZE THAT INTRAOSSEOUS VANCOMYCIN WILL ACHIEVE SIGNIFICANTLY HIGHER DRUG LEVELS IN THE AMPUTATION STUMP AREA, REDUCE THE RATE OF SURGICAL SITE INFECTIONS (SSI), RESULT IN SMALLER INCREASES IN SERUM CREATININE LEVELS DUE TO LOWER SYSTEMIC EXPOSURE, AND DECREASE THE NECESSITY FOR REOPERATION (RTOR) IN PATIENTS UNDERGOING TRANSTIBIAL AMPUTATION.

METHODOLOGY AND INTERVENTIONS: PATIENTS ARE RANDOMIZED IN A 1:1 RATIO INTO TWO TREATMENT ARMS:

IO GROUP: DURING THE AMPUTATION PROCEDURE, 500 MG OF VANCOMYCIN IS ADMINISTERED VIA THE INTRAOSSEOUS ROUTE DIRECTLY AT THE AMPUTATION SITE.

IV GROUP: PATIENTS RECEIVE 500 MG OF VANCOMYCIN INTRAVENOUSLY 15-30 MINUTES PRIOR TO THE SURGICAL INCISION.

PHARMACOKINETIC EVALUATION (PRIMARY FOCUS): VANCOMYCIN CONCENTRATIONS WILL BE MEASURED FROM BOTH THE STUMP SITE (LOCAL TISSUE) AND SYSTEMIC CIRCULATION (PERIPHERAL BLOOD) TO COMPARE THE DISTRIBUTION AND CONCENTRATION GRADIENTS OF THE DRUG BETWEEN THE TWO ADMINISTRATION ROUTES. SAMPLES WILL BE COLLECTED INTRAOPERATIVELY TO DETERMINE IF THE IO ROUTE BYPASSES VASCULAR INSUFFICIENCY.

FOLLOW-UP AND OUTCOME EVALUATION: PATIENTS WILL BE FOLLOWED POSTOPERATIVELY ON DAYS 1,2,3,7 AND 30 FOR CLINICAL OUTCOMES ACCORDING TO CDC CRITERIA. SECONDARY OUTCOMES, INCLUDING SERUM CREATININE LEVELS TO MONITOR RENAL SAFETY AND REOPERATION RATES (REVISION AMPUTATION, DEBRIDEMENT), WILL BE TRACKED FOR UP TO 90 DAYS. MULTIVARIATE LOGISTIC REGRESSION WILL BE USED TO ADJUST FOR CONFOUNDING FACTORS SUCH AS AGE, GENDER, AND HBA1C LEVELS.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turkey (Türkiye), 34010
        • Recruiting
        • Basaksehir Cam ve Sakura City Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intraosseous Vancomycin
500 mg Vancomycin hydrochloride dissolved in of %0.9 NaCl, administered directly into the intramedullary space.
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.
Active Comparator: Intravenous Vancomycin
500 mg Vancomycin hydrochloride administered via peripheral intravenous infusion
Drug: Intravenous Vancomycin
A single dose of 500 mg Vancomycin is administered via systemic intravenous infusion for standard prophylactic care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LOCAL AND SYSTEMIC VANCOMYCIN CONCENTRATIONS
Time Frame: NTRAOPERATIVE (MEASURED DURING SURGERY, APPROXIMATELY 15-30 MINUTES AFTER DRUG ADMINISTRATION).
COMPARISON OF VANCOMYCIN CONCENTRATIONS (MCG/ML) MEASURED FROM THE SURGICAL SITE (LOCAL STUMP AREA) AND THE SYSTEMIC CIRCULATION (PERIPHERAL BLOOD). THE GOAL IS TO EVALUATE THE PHARMACOKINETIC EFFICIENCY OF INTRAOSSEOUS (IO) ADMINISTRATION VERSUS INTRAVENOUS (IV) ADMINISTRATION IN REACHING TARGET LEVELS AT THE AMPUTATION SITE IN PATIENTS WITH PERIPHERAL VASCULAR DISEASE.
NTRAOPERATIVE (MEASURED DURING SURGERY, APPROXIMATELY 15-30 MINUTES AFTER DRUG ADMINISTRATION).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
REOPERATION RATE (RTOR)
Time Frame: UP TO 30 DAYS POSTOPERATIVELY.
ECESSITY FOR ADDITIONAL SURGICAL INTERVENTION, SUCH AS REVISION AMPUTATION OR DEBRIDEMENT.
UP TO 30 DAYS POSTOPERATIVELY.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Başakşehir Çam & Sakura City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2025

Primary Completion (Estimated)

May 4, 2026

Study Completion (Estimated)

June 19, 2026

Study Registration Dates

First Submitted

January 4, 2026

First Submitted That Met QC Criteria

January 4, 2026

First Posted (Actual)

January 14, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-96317027-514.10-285164594

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in the final article, after de-identification (including text, tables, figures, and appendices), will be made available to researchers whose proposed use of the data has been approved by a methodologically sound proposal.

IPD Sharing Time Frame

Data will be available beginning 2 months and ending 12 months after article publication.

IPD Sharing Access Criteria

Data will be shared with researchers who provide a methodologically sound proposal to achieve the objectives in the approved proposal. Proposals should be directed to the corresponding author's email.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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