Meta-Analysis of the Safety and Efficacy of Flap Reconstruction in the Treatment of Diabetic Foot Ulcers

OBJECTIVE : To systematically evaluate the safety and efficacy of flap reconstruction surgery and the associated influential factors in the treatment of diabetic foot ulcers (DFUs) and to provide an evidence-based basis for clinical flap selection and surgical strategies. METHODS : The PubMed, Embase, Web of Science and Cochrane Library databases were searched to identify studies on comparative or single-arm flap reconstruction for the treatment of DFU, including RCTs, cohort studies and case series published between 1998 and 2022. Two investigators independently screened the literature, extracted the data, and assessed the risk of bias (Cochrane tool with ROBINS-I). Meta-analysis was performed using RevMan 5.4, with outcome metrics including mortality, limb loss rate, flap failure rate, and subgroup analyses (flap type and regional differences) and wrote the main manuscript text. One investigator prepared figures. All authors reviewed the manuscript. RESULTS : A total of 45 studies were included. The results of the meta-analysis revealed that postoperative mortality (HR=5.83; 95% CI 3.65–9.31), limb loss rate (HR=11.09; 95% CI 7.22–17.03) and free flap failure rate (HR=10.01; 95% CI 8.31–12.05) significantly increased. Subgroup analyses revealed that the risk of free flap limb loss was significantly greater than that of non-free flaps (HR=17.86 vs. 1.94; P=0.02); the risk of limb loss was greater in Europe (HR=22.97) and North America (HR=17.42) than in East Asia (HR=5.85; P<0.001), and there was no regional difference in mortality (P=0.67). The results of the sensitivity analysis were robust, with heterogeneity arising mainly from differences in study design and patient characteristics. CONCLUSION : Although flap reconstruction can repair DFU trauma, the risks of postoperative death, amputation, and flap failure are high. Individualized surgical protocols, prioritization of non-free flaps for low- and intermediate-risk patients, and enhanced multidisciplinary collaboration and postoperative management are recommended. More high-quality studies are needed to validate the long-term efficacy of different flap techniques.