AIMS/HYPOTHESIS Foot ulceration is a serious complication for people with diabetes that results in high levels of morbidity for individuals and significant costs for health and social care systems. Nineteen systematic reviews of preventative interventions have been published, but none provides a reliable numerical summary of treatment effects. The aim of this study was to systematically review the evidence from RCTs and, where possible, conduct meta-analyses to make the best possible use of the currently available data. METHODS We conducted a systematic review and meta-analysis of RCTs of preventative interventions for foot ulceration. OVID MEDLINE and EMBASE were searched to February 2019 and the Cochrane Central Register of Controlled Trials to October 2018. RCTs of interventions to prevent foot ulcers in people with diabetes who were free from foot ulceration at trial entry were included. Two independent reviewers read the full-text articles and extracted data. The quality of trial reporting was assessed using the Cochrane Risk of Bias tool. The primary outcome of foot ulceration was summarised using pooled relative risks in meta-analyses. RESULTS Twenty-two RCTs of eight interventions were eligible for analysis. One trial of digital silicone devices (RR 0.07 [95% CI 0.01, 0.55]) and meta-analyses of dermal infrared thermometry (RR 0.41 [95% CI 0.19, 0.86]), complex interventions (RR 0.59 [95% CI 0.38, 0.90], and custom-made footwear and offloading insoles (RR 0.53 [95% CI 0.33, 0.85]) showed beneficial effects for these interventions. CONCLUSIONS/INTERPRETATION Four interventions were identified as being effective in preventing foot ulcers in people with diabetes, but uncertainty remains about what works and who is most likely to benefit.

中文翻译：

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预防糖尿病的足部溃疡：RCT数据的系统评价和荟萃分析。

目的/假说足溃疡是糖尿病患者的严重并发症，导致个人高发病率，并给医疗和社会护理系统带来可观的成本。已经发表了19篇关于预防性干预的系统评价，但是都没有提供有关治疗效果的可靠数字摘要。这项研究的目的是系统地审查来自随机对照试验的证据，并在可能的情况下进行荟萃分析，以充分利用当前可获得的数据。方法我们对脚溃疡的预防性干预措施的RCT进行了系统的回顾和荟萃分析。截至2019年2月，已搜索OVID MEDLINE和EMBASE，至2018年10月，已搜索Cochrane对照试验中央注册簿。包括了在试验开始时没有足溃疡的糖尿病患者预防足溃疡的干预措施的RCT。两名独立的审阅者阅读了全文并提取了数据。使用Cochrane偏倚风险工具评估了试验报告的质量。在荟萃分析中使用合并的相对风险总结了足溃疡的主要结局。结果八项干预措施中的二十二项RCT符合分析条件。一项数字化硅胶器械试验（RR 0.07 [95％CI 0.01，0.55]）和皮肤红外测温的荟萃分析（RR 0.41 [95％CI 0.19，0.86]），复杂干预措施（RR 0.59 [95％CI 0.38， 0.90]和定制鞋类和减负鞋垫（RR 0.53 [95％CI 0.33，0.85]）对这些干预措施均显示出有益的效果。