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The effect of vancomycin loading dose in diabetic foot patients

Evaluation of vancomycin loading dose effect on clinical outcome in patients with diabetic foot infection: a randomize, double blind clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240729062573N1
Enrollment
80
Registered
2024-09-16
Start date
2024-09-22
Completion date
Unknown
Last updated
2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Investigating the effect of vancomycin loading dose in diabetic foot patients. Diabetes mellitus due to underlying condition

Interventions

Intervention 1: Forty drug candidate patients receiving Laoding dose with a dose (20-35 mg/kg) of 25 mg/kg vancomycin (vancomycin injection vial of Dena Pharmaceutical Company) (maximum 2 grams, even

Sponsors

Yazd University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Diabetic patients over 18 years of age with purulent drainage, swelling, and redness in the leg area below the knee who are admitted to the infectious department of Shahid Sadoughi Hospital in Yazd and are candidates for treatment with vancomycin injection form to treat diabetic foot infection Receive vancomycin for at least 7 days

Exclusion criteria

Exclusion criteria: history of sensitivity to vancomycin BMI=30 vancomycin-resistant microorganism in the antibiogram Pregnancy, breastfeeding under hemodialysis, peritonealdialysis, or CCRT Patients who have had effective antibiotic therapy with an effective dose and treatment period during the last 48 hours are excluded from the study unless Have evidence of previous antibiotic treatment failure, or antibiotic resistance to previous cases. Patients who are treated with antibiotics for other reasons Patients who are treated with topical antibiotic on diabetic foot ulcer Receiving vancomycin for surgical prophylaxis

Design outcomes

Primary

MeasureTime frame
Comparison of clinical outcomes in patients with diabetic foot infection in two groups receiving vancomycin loading dose and the group not receiving it. Timepoint: At the beginning of the study and during the study for up to 7 days. Method of measurement: Examination of clinical outcome based on clinical manifestations.;Comparison of laboratory results in patients with diabetic foot infection in two groups receiving vancomycin loading dose and the group not receiving it. Timepoint: At the beginning of the study and during the study up to 7 days. Method of measurement: Examining laboratory results based on inflammatory factors, Erythrocyte Sedimentation rate and C-reactive protein and white blood cell count.;Comparison of the occurrence of acute kidney injury in patients with diabetic foot infection in two groups receiving vancomycin loading dose and the group not receiving it. Timepoint: At the beginning of the study and during the study up to 7 days. Method of measurement: Assessment of acute kidney injury based on serum creatinine and urine volume.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNazanin Nematelahi

Yazd University of Medical Sciences

Nematelahinazanin@gmail.com+98 35 3820 3865

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026