Outcomes of flap reconstruction for diabetic foot ulcers: a systematic review and meta-analysis of Clinical Studies

Background: People with diabetic foot ulcers (DFU) are at risk of major amputation, which is associated with a high mortality rate (exceeding 50% at five years) and reduced quality of life. We hypothesise that flap reconstruction of diabetic foot ulcers improves patient outcomes in comparison to standard treatment modalities including major amputation. Methods: MEDLINE, EMBASE, the Cochrane Library and grey literature were searched on 9 th February 2022. Comparative and single-arm studies reporting outcomes of DFU treated with local, regional or free flaps including function, limb loss, mortality, and flap failure were included. Risk of bias was assessed and meta-analysis of proportions was performed. Results: 3,878 records were retrieved, of which 45 met the inclusion criteria, including 1,681 patients who underwent flap reconstruction of DFU. Free flaps were most commonly performed (n = 1,257, 72%). Only one study utilised a verified functional outcome measure. At 12 months, the mortality rate was 6.35% (95% C.I. 3.89 – 10.20), limb loss rate was 11.39% (95% C.I. 7.02 – 17.96) and the free flap failure rate was 9.95% (95% C.I. 8.19 – 12.05). All studies were at high risk of bias. A comparative meta-analysis of interventions was not performed due to study method and outcome heterogeneity. Conclusions: There is short-term evidence that flap reconstruction (including microsurgical transfer) has low mortality, limb loss and flap failure rates. However, there are limited high-quality comparative studies, and uncertainty remains regarding the outcome of DFU flap reconstruction in comparison to other treatments.