Jones Aled Wyn, Makanjuola Abraham, Bray Nathan, Prior Yeliz, Parker Daniel, Nester Christopher, Tang Jinghua, Jiang Liudi
Academy for Health Equity, Prevention and Wellbeing, Bangor University, Bangor, UK.
Faculty of Life Sciences and Education, University of South Wales, Cardiff, UK.
Diabetol Metab Syndr. 2024 Jul 24;16(1):172. doi: 10.1186/s13098-024-01392-y.
Therapeutic offloading devices, including insoles, shoes, and other orthoses, are some of the most commonly used interventions to treat or prevent diabetic foot ulceration. Custom-made offloading devices are increasingly used to offset the development of foot ulcers. However, whether these devices are more effective than prefabricated standard offloading devices is uncertain. Therefore, this systematic review collates and examines evidence on the efficacy of custom-made offloading devices in preventing foot ulcer incidence and recurrence in people diagnosed with diabetes.
Five scientific databases were searched, covering 2011-2023. Initial searches and screening were carried out independently by two researchers. Studies meeting the inclusion criteria were further examined through additional screenings, and critical appraisal. Data relevant to the review aims were extracted and analysed within a narrative synthesis.
Of the 1,715 articles found in the initial searches, nine papers were found to meet inclusion criteria and were included in the review. The evidence shows that custom-made offloading devices are likely to be more effective for reducing or preventing diabetic foot ulcers than standard offloading devices. However, due to a lack of data it remains uncertain whether custom-made offloading devices are more cost-effective for preventing ulceration compared to standard insoles. Likewise, due to measurement heterogeneity between studies and lack of data, it is unclear whether adherence is higher in users of custom-made offloading devices, and whether such devices deliver significantly greater reductions in peak pressure as compared to standard offloading devices.
Custom-made offloading devices are more effective than standard devices for preventing diabetic foot ulceration, and we recommended their use when feasible; however, there remains uncertainty regarding their cost-effectiveness compared to standard insoles and offloading devices.
治疗性减负装置，包括鞋垫、鞋子及其他矫形器，是治疗或预防糖尿病足溃疡最常用的干预措施之一。定制的减负装置越来越多地用于抵消足部溃疡的发展。然而，这些装置是否比预制的标准减负装置更有效尚不确定。因此，本系统评价整理并审查了关于定制减负装置在预防糖尿病患者足部溃疡发生和复发方面疗效的证据。
检索了五个科学数据库，涵盖2011年至2023年。最初的检索和筛选由两名研究人员独立进行。符合纳入标准的研究通过额外筛选和严格评价进行进一步审查。在叙述性综合分析中提取并分析与评价目的相关的数据。
在最初检索中找到的1715篇文章中，有9篇论文符合纳入标准并被纳入评价。证据表明，定制的减负装置在减少或预防糖尿病足溃疡方面可能比标准减负装置更有效。然而，由于缺乏数据，与标准鞋垫相比，定制减负装置在预防溃疡方面是否更具成本效益仍不确定。同样，由于研究之间的测量异质性和数据缺乏，尚不清楚定制减负装置使用者的依从性是否更高，以及与标准减负装置相比，此类装置是否能显著降低峰值压力。
定制减负装置在预防糖尿病足溃疡方面比标准装置更有效，我们建议在可行时使用；然而，与标准鞋垫和减负装置相比，其成本效益仍存在不确定性。
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