The challenge of multicenter studies in diabetic patients with foot infections

Background: A complexity of factors determines outcome of foot ulcer infections in diabetic subjects. Variations in patient characteristics, treatment strategies and differences in health care systems may influence outcome. Objective: To evaluate the homogeneity in patients with diabetic foot ulcer infections of sufficient severity to warrant antibiotic treatment in three different European foot care centres. Method: A prospective, observational data collection study with agreed on definitions and the same inclusion and exclusion criteria according to a standardised protocol. Patient and wound characteristics, laboratory tests and physical measurements, antibiotic and surgical treatment during 28 days were recorded in 93 patients. Results: We found significant differences in patient and wound characteristics, in rate and duration of hospitalisation, in antibiotic and surgical treatment, in rate of resolution of infection and in wound healing between centres. Conclusions: Despite using agreed on definitions and the same inclusion and exclusion criteria according to a standardized protocol the heterogeneity between centres of included patients, wound characteristics, management and outcome were surprising. In future multicenter studies, evaluating the effects of a specific treatment of infected foot ulcers in diabetic patients, clear definitions, algorithm for decision making, treatment strategy protocols and knowledge about variations in treatment strategies and healthcare/reimbursement systems in participating centres are needed.