Efficacy and safety of antibiotic-loaded bone cement in the treatment of diabetic foot: a systematic review and meta-analysis.

Objective: Diabetic foot ulcers (DFUs) represent a serious diabetic complication requiring effective therapeutic interventions. This systematic review and meta-analysis evaluates the clinical outcomes and safety profile of antibiotic-loaded bone cement (ALBC), an innovative localized drug delivery approach, for managing DFU patients. Methods: From their inception through October 2025, a comprehensive literature search was conducted across multiple databases including PubMed, Cochrane Library, Web of Science, CNKI, Wanfang, VIP, and CBM Database. Our analysis focused exclusively on randomized clinical trials that compared ALBC therapy with standard treatment protocols in diabetic foot cases. The primary endpoints assessed were wound healing time and clinical effective rate. Secondary outcome measures encompassed length of hospitalization, surgical intervention frequency, visual analog scale (VAS) for pain assessment, and limb preservation rates. Statistical analysis was performed using R statistical software with random-effects modeling to account for potential heterogeneity. Results: 22 RCTs involving 1,295 patients were included. All studies were conducted in China. Pooled analysis demonstrated that ALBC significantly shortened wound healing time (Mean Difference [MD] = -7.10 days, 95% CI: -12.88 to -1.32, p = 0.016, I² = 96%) and improved the clinical effective rate (Odds Ratio [OR] = 4.05, 95% CI: 2.70 to 6.07, p < 0.001, I² = 9.9%) compared to control. Furthermore, ALBC reduced the number of surgeries. The standardized mean difference (SMD) was -1.88, with a 95% CI from -3.29 to -0.47. It also reduced hospital stay, with a mean difference (MD) of -8.56 days and a 95% CI from -12.33 to -4.79. The VAS pain score was reduced, with an SMD of -1.29 and a 95% CI from -1.89 to -0.69. Additionally, the amputation rate was reduced, with an odds ratio (OR) of 0.19 and a 95% CI from 0.07 to 0.50. Subgroup and sensitivity analyses generally supported the robustness of these findings. No significant publication bias was detected. Conclusion: Antibiotic-loaded bone cement (ALBC) therapy demonstrates significant efficacy and safety in managing diabetic foot ulcers, promoting rapid tissue regeneration while minimizing adverse effects. This intervention correlates with enhanced wound closure rates, diminished pain perception, decreased surgical intervention frequency, reduced hospitalization duration, and lower extremity amputation incidence. Current evidence substantiates the clinical implementation of ALBC therapy; however, additional rigorously designed investigations are warranted to strengthen the external validity of these findings across diverse patient populations.