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

NCT07338773 | Recruiting Phase 4 DMC

• 1 other identifier: E-96317027-514.10-285164594
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

DIABETIC FOOT, VANCOMYCIN INTRAOSSEOUS, AMPUTATION

Outcome Measures

Primary Outcomes (1)

• LOCAL AND SYSTEMIC VANCOMYCIN CONCENTRATIONS

  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 Outcomes (1)

• REOPERATION RATE (RTOR)

  UP TO 30 DAYS POSTOPERATIVELY.

Study Arms (2)

Intraosseous Vancomycin

EXPERIMENTAL

500 mg Vancomycin hydrochloride dissolved in of %0.9 NaCl, administered directly into the intramedullary space.

Drug: Intraosseous Vancomycin

Intravenous Vancomycin

ACTIVE COMPARATOR

500 mg Vancomycin hydrochloride administered via peripheral intravenous infusion

Drug: Intravenous Vancomycin

Interventions

Intraosseous Vancomycin DRUG

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.

Intraosseous Vancomycin

Intravenous Vancomycin DRUG

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

Intravenous Vancomycin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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.

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

Study Sites (1)

Basaksehir Cam ve Sakura City Hospital

Istanbul, Istanbul, 34010, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Wininger AE, Gurusamy P, Sullivan TC, Serpelloni S, Taraballi F, Park KJ, Brown TS. Intraosseous Versus Intravenous Vancomycin in Tourniquetless Primary Total Knee Arthroplasty: A Randomized Trial. J Arthroplasty. 2024 Sep;39(9S2):S224-S228. doi: 10.1016/j.arth.2024.02.083. Epub 2024 Mar 8.

  PMID: 38462143 RESULT

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Central Study Contacts

lezgin mert

CONTACT

+905056003904; lezginmert@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic surgeon

Model Details: PROSPECTIVE, RANDOMIZED, PARALLEL-ASSIGNMENT, CONTROLLED CLINICAL TRIAL. PATIENTS ARE RANDOMLY ASSIGNED TO EITHER THE INTRAOSSEOUS (IO) VANCOMYCIN GROUP OR THE INTRAVENOUS (IV) VANCOMYCIN GROUP IN A 1:1 RATIO.

Study Record Dates

• First Submitted: January 4, 2026
• First Posted: January 14, 2026
• Study Start: September 3, 2025
• Primary Completion: May 4, 2026
• Study Completion (Estimated): June 19, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available beginning 2 months and ending 12 months after article publication.
• 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.

Locations

TU (1)