背景:治疗性卸载装置,包括鞋垫,鞋子,和其他矫形器,是治疗或预防糖尿病足溃疡的一些最常用的干预措施。定制的卸载装置越来越多地用于抵消足部溃疡的发展。然而,这些设备是否比预制标准卸载设备更有效尚不确定。因此,本系统综述整理并研究了有关定制卸载装置在预防糖尿病患者足部溃疡发生率和复发方面的有效性的证据.
方法:搜索了五个科学数据库,涵盖2011-2023年。初步搜索和筛选由两名研究人员独立进行。通过额外的筛查进一步检查符合纳入标准的研究,和批判性评估。在叙述性综合中提取并分析了与审查目标相关的数据。
结果:在初始搜索中发现的1,715篇文章中,9篇论文被发现符合纳入标准,并被纳入审查。证据表明,定制的卸载装置可能比标准卸载装置更有效地减少或预防糖尿病足溃疡。然而,由于缺乏数据,与标准鞋垫相比,定制卸载装置在预防溃疡方面是否更具成本效益仍然不确定.同样,由于研究之间的测量异质性和缺乏数据,目前还不清楚定制卸载设备用户的依从性是否更高,以及与标准卸载装置相比,此类装置是否能显著降低峰值压力。
结论:在预防糖尿病足溃疡方面,定制卸载装置比标准装置更有效,我们建议在可行的情况下使用它们;然而,与标准鞋垫和卸载装置相比,它们的成本效益仍然存在不确定性。
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.