Leg or Foot Amputation Clinical Trials

Clinical trials related to Leg or Foot Amputation Procedure

Does Intraosseous Compared With Intravenous Vancomycin Alter Local Exposure, Systemic Safety, and Early Outcomes in Patients With Ischemic Diabetic Foot Undergoing Below-knee Amputation? A Randomized Trial

Status: Completed
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age 18 years or older

• Diagnosis of diabetes mellitus

• Diabetic foot infection with distal ischemia

• Scheduled to undergo below-knee amputation

• Absence of a feasible further revascularization option, as determined by the cardiovascular surgery and interventional radiology teams

• Adequate circulation at and proximal to the planned below-knee amputation level for stump healing

• Ability to provide written informed consent

Locations
Other Locations
Turkey
Basaksehir Cam ve Sakura City Hospital
Istanbul
Time Frame
Start Date: 2025-08-06
Completion Date: 2026-06-21
Participants
Target number of participants: 40
Treatments
Experimental: Intraosseous Vancomycin
Participants received 500 mg of vancomycin diluted in 100 mL of 0.9% normal saline via intraosseous administration into the proximal tibial metaphysis immediately before skin incision.
Active_comparator: Intravenous Vancomycin
Participants received 500 mg of vancomycin intravenously at the same preincision time point before below-knee amputation.
Sponsors
Leads: Başakşehir Çam & Sakura City Hospital

This content was sourced from clinicaltrials.gov