Endovascular Treatment of Infrapopliteal Arterial Disease in Patients with Diabetic Foot Ulcer: A Systematic Review of Randomised Controlled Trials

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BACKGROUND: Diabetes mellitus is strongly associated with peripheral arterial disease and foot ulceration, frequently requiring revascularisation to promote wound healing. Percutaneous transluminal angioplasty (PTA) is widely used for infrapopliteal arterial disease; however, its effectiveness for ulcer healing compared with alternative strategies remains uncertain. OBJECTIVE: To assess the effects of PTA in infrapopliteal arterial disease for diabetic ulcer healing. METHODS: We conducted a systematic review of randomised controlled trials identified through MEDLINE, Embase, LILACS, CENTRAL, CINAHL, ClinicalTrials.gov, the World Health Organisation International Clinical Trials Registry Platform, and grey literature sources. Study selection and data extraction were performed independently. Risk of bias was assessed using the Cochrane Risk of Bias tool. Meta-analyses were undertaken where appropriate, and certainty of evidence was evaluated. RESULTS: Of 34 542 records screened, six randomised controlled trials (945 total participants) were included. Compared with venous bypass, PTA was associated with a higher likelihood of ulcer healing (risk ratio 1.20; 95% confidence interval 1.07-1.33; p = .0001; low-certainty evidence). No statistically significant differences were observed between revascularisation strategies for mortality or major amputation. Similarly, no significant differences were identified in comparisons of PTA versus drug-coated balloon or drug-coated stent interventions. CONCLUSION: PTA may be associated with improved arterial ulcer healing compared with venous bypass in patients with diabetes, without clear differences in mortality or amputation rates. However, the certainty of evidence is low, and these findings should be interpreted with caution. Further adequately powered randomised trials are required to clarify the comparative effectiveness of infrapopliteal revascularisation strategies.

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