Abstract
Background Diabetic foot ulcers (DFUs) are a serious complication of diabetes mellitus (DM), significantly contributing to mortality and morbidity in this population. Annually, approximately 18.6 million people with DM develop DFUs, with up to 34% experiencing a foot ulcer during their lifetime. DFUs are a leading cause of limb and life-threatening infections, lower limb amputations, and increased hospitalisations. Despite these public health challenges, there is a lack of research focusing on the primary prevention of DFUs, particularly the prevention of first-ever ulceration. Objectives To systematically review and synthesise research evidence and meta-analysis of previous research findings and derive conclusions regarding risk factors for the development of first-ever foot ulcers in patients with diabetes. Methods and analysis Four English and three Chinese databases will be utilised to identify eligible studies reporting risk factors for the first-ever foot ulcers in patients with diabetes. Two independent researchers will review the literature, extract relevant data, and assess the risk of bias of included studies using the Newcastle-Ottawa Scale. Pooled odds ratios (ORs) and standardised mean differences (SMD) with 95% confidence intervals (CIs) for nominal and continuous data will be calculated employing either a fixed-effects or random-effects model based on heterogeneity (I² < 50% for fixed-effects and I² > 50% for random-effects models). All statistical analyses will be conducted using Stata Software Version 16. Systematic review registration PROSPERO (CRD42024508855)
Published Version
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