Systematic review of the efficacy and safety of biologically and tissue-derived therapies for the treatment of diabetic foot

Background: Diabetic foot ulcers are a common and serious complication in diabetic patients, and traditional treatments have limited healing rates. Autologous cells and related products, as an emerging therapy, require systematic evaluation for their efficacy and safety. Objective: To systematically evaluate and meta-analyze the efficacy and safety of autologous cells and related products in the treatment of diabetic foot ulcers. Methods: Relevant randomized controlled trials up to November 2025 were searched in PubMed and Embase databases. Patients with diabetic foot ulcers were included, and the intervention was autologous cell therapy. Data on healing rate, percentage reduction in ulcer area, and healing days were extracted and meta-analyzed using RevMan 5.3. Results: A total of 26 randomized controlled trials (RCTs) involving 2,214 patients were included. The autologous cell therapy group showed a significantly higher rate of complete healing than the control group (RR = 0.54, 95% CI: 0.45). The difference in ulcer area reduction was significantly greater (MD = 24.6%, 95%CI: 18.3-30.9, P<0.001) and healing time was significantly shorter (MD= -48.8 days, 95% CI: -74.19 to -23.48, P = 0.0002). There were no significant differences in adverse events such as amputation and mortality between the two groups. In conclusion, autologous cell therapy can significantly improve the healing rate and accelerate ulcer healing in diabetic foot ulcers, with good safety, making it a promising treatment option. Systematic review registration: https://www.crd.york.ac.uk/prospero/, identifier CRD420261293843.