Diabetic foot ulcers (DFU) represent prevalent chronic wounds with significant negative impacts on patients' health and socioeconomic status. Antibiotic bone cement (ABC) has emerged as a therapeutic option, though its efficacy and safety require comprehensive evaluation.

To perform a meta-analysis of randomized controlled trials (RCT) assessing the efficacy and safety of ABC for DFU, thereby providing evidence-based guidance for clinical practice.

We systematically searched CNKI, Wanfang Data, VIP, China Biomedical Literature Database, PubMed, Cochrane Library, Embase, and Web of Science for RCT published until January 2025. Thirteen RCT involving 843 patients were included. The intervention group received ABC combined with vacuum sealing drainage (VSD), while controls received VSD alone. Outcomes included wound healing time, clinical efficacy rate, bacterial clearance time, hospital stay, surgical frequency, amputation rate, visual analogue scale (VAS) scores, and adverse events. RevMan 5.3 was used with random-effects models for heterogeneous data.

The meta-analysis demonstrated that combined ABC therapy significantly: reduced wound healing time (MD=-14.46, 95%CI=-19.69 to -9.23; P<0.05), increased clinical efficacy rates (OR=7.81, 95%CI=3.94 to 17.48, P<0.05), shortened bacterial clearance time (MD=-4.04, 95%CI=-5.13 to -2.94, P<0.05), decreased positive bacterial cultures at 1-week post-treatment (OR=0.27, 95%CI=0.14 to 0.50, P<0.05), lowered amputation rates (OR=0.14, 95%CI=0.03 to 0.62, P=0.01), reduced surgical frequency (MD=-1.77, 95%CI=-2.52 to -1.03, P<0.05); decreased VAS scores (MD=-1.96, 95%CI=-2.35 to -0.57, P<0.05). Additionally, no adverse events were reported across the included studies. For wound healing time, it was divided into Wagner 5 group and non-Wagner 5 group according to different research subjects, and divided into combination group and monotherapy group according to different types of antibiotics. The results of the non-Wagner 5 group showed that ABC combined with VSD treatment could significantly shorten the wound healing time of DFU patients compared with VSD treatment alone (MD=-6.31, 95%CI=-7.88 to -4.74, P<0.05); The results of the Wagner grade 5 group showed that there was no significant difference between the experimental group and the control group (MD=-8.02, 95%CI=-20.11 to 4.07, P=0.19). The results of the antibiotic alone group showed that ABC combined with VSD treatment could shorten the wound healing time of DFU patients compared with VSD alone (MD=-4.52, 95%CI=-5.81 to -3.23, P<0.05). The results of the combination antibiotic group showed that ABC combined with VSD treatment could significantly shorten the wound healing time of DFU patients compared with VSD alone (MD=-14.21, 95%CI=-18.20 to -10.21, P<0.05). For the length of hospitalization, according to the age of the study subjects, they were divided into the average age greater than 60 years old group and the average age less than 60 years group. The results of the mean age group greater than 60 years showed that ABC combined with VSD treatment could shorten the hospital stay of DFU patients compared with VSD treatment alone (MD=-6.82, 95%CI=-10.93 to -2.71, P=0.001). The results of the average age less than 60 years old group showed that there was no significant difference between the experimental group and the control group (MD=-5.11, 95%CI=-17.78 to 7.56, P=0.45). For the number of surgeries, according to the wound treatment methods, it is divided into a group with skin graft and a group without skin grafting. The results of the no skin graft group showed that ABC combined with VSD treatment could reduce the number of surgeries in DFU patients compared with VSD treatment alone (MD=-1.79, 95%CI=-2.13 to -1.46, P<0.05). The results of the skin graft group showed that ABC combined with VSD treatment could significantly reduce the number of surgeries in patients with DFU compared with VSD treatment alone (MD=-1.89, 95%CI=-3.27 to -0.50, P=0.008). Sensitivity analysis was performed and the results of this study were found.

In this study, ABC combined with VSD is a safe and effective therapy for DFU, especially for non-Wagner grade 5 patients and the elderly, and the combination of antibiotics and skin grafting can further enhance the efficacy.