To compare the efficacy and safety of faropenem versus amoxicillin-clavulanic acid in patients of diabetic foot ulcers: a randomised, open label, controlled clinical study

Diabetic foot ulcers are a major complication of diabetes leading to significant morbidity mortality and healthcare costs. In India the prevalence is particularly high with diabetic foot ulcers being a leading cause of non traumatic limb amputations. Diabetic foot ulcers are often polymicrobial involving both Gram positive and Gram negative bacteria including multidrug resistant organisms. The increasing prevalence of antibiotic resistance complicates treatment and increases the risk of poor outcomes.

Effective outpatient management and step down therapy require potent oral antibiotics. While amoxicillin clavulanic acid is a well established option emerging resistance and limited efficacy against some pathogens necessitate evaluation of alternatives.

Faropenem a newer carbapenem and the only orally available antibiotic in its class offers broad spectrum coverage and may be effective against resistant organisms commonly found in diabetic foot ulcers. However there is limited clinical data directly comparing its efficacy and safety to established regimens such as amoxicillin clavulanic acid. There is a lack of robust comparative clinical studies evaluating the efficacy safety and quality of life outcomes of faropenem versus amoxicillin clavulanic acid in the Indian population with diabetic foot ulcers.

This study aims to address this gap and guide the development of evidence based guidelines aiding healthcare professionals in making informed decisions tailored to individual patient needs. Hence this study is ethically justified. All medications assessed in this study are approved by the Central Drugs Standard Control Organisation and are already marketed and available in the Indian market. The study will be conducted after obtaining approval from the Institutional Ethical Committee. Written informed consent will be obtained from all enrolled patients. Personal information will be kept strictly confidential. Data collected during the study will be used for academic purposes only.