The Role of Negative Pressure Therapy in Diabetic Foot Ulcer: A Meta-Analysis.

Diabetic foot ulcer (DFU) is a severe complication, often leading to amputation. Negative pressure wound therapy (NPWT) is an advanced treatment option requiring further consolidated evidence. This study evaluated the effectiveness and safety of NPWT versus conventional wound care for DFU, focusing on wound healing, amputation prevention, and adverse events (AEs). We systematically searched PubMed, Cochrane Library, Embase, and Web of Science for randomized controlled trials (RCTs) from inception until October 2025. Twenty-three RCTs involving 2086 participants were included. Two reviewers independently selected studies. Outcomes included wound healing rate, ulcer area reduction, amputation rate, and adverse events. Pooled odds ratios (OR) and standardized mean differences (SMD) with 95% confidence intervals (CI) were calculated using random-effects models. NPWT significantly improved the wound healing rate (OR 4.48, 95% CI 2.58-7.77), led to a greater reduction in ulcer area (SMD 1.26, 95% CI 0.70-1.82), and substantially lowered amputation risk (OR 0.35, 95% CI 0.19-0.64) compared to conventional care. No significant difference was found in adverse events (OR 0.98, 95% CI 0.56-1.71). Subgroup analyses confirmed benefits across ages, follow-up durations, and control dressings. The healing benefit was most pronounced in less severe ulcers (Wagner grade < 2), while amputation protection was consistent across severities. NPWT is an effective and safe strategy for DFU, significantly accelerating wound healing and reducing amputation risk, supporting its integration as a cornerstone adjunctive therapy.