Rehabilitation Medicine, Amsterdam UMC Location University of Amsterdam, Meibergdreef 9, Amsterdam, the Netherlands.
Rehabilitation & Development, Amsterdam Movement Sciences, Amsterdam, the Netherlands.
Trials. 2023 Oct 12;24(1):663. doi: 10.1186/s13063-023-07635-z.
Preventing foot ulcers in people with diabetes can increase quality of life and reduce costs. Despite the availability of various interventions to prevent foot ulcers, recurrence rates remain high. We hypothesize that a multimodal treatment approach incorporating various footwear, self-management, and education interventions that matches an individual person's needs can reduce the risk of ulcer recurrence with beneficial cost-utility. The aim of this study is to assess the effect on foot ulcer recurrence, footwear adherence, and cost-utility of an integrated personalized assistive devices approach in high-risk people with diabetes.
In a parallel-group multicenter randomized controlled trial, 126 adult participants with diabetes mellitus type 1 or 2, loss of protective sensation based on the presence of peripheral neuropathy, a healed plantar foot ulcer in the preceding 4 years, and possession of any type of custom-made footwear will be included. Participants will be randomly assigned to either enhanced therapy or usual care. Enhanced therapy consists of usual care and additionally a personalized treatment approach including pressure-optimized custom-made footwear, pressure-optimized custom-made footwear for indoor use, at-home daily foot temperature monitoring, and structured education, which includes motivational interviewing and personalized feedback on adherence and self-care. Participants will be followed for 12 months. Assessments include barefoot and in-shoe plantar pressure measurements; questionnaires concerning quality of life, costs, disease, and self-care knowledge; physical activity and footwear use monitoring; and clinical monitoring for foot ulcer outcomes. The study is powered for 3 primary outcomes: foot ulcer recurrence, footwear adherence, and cost-utility, the primary clinical, patient-related, and health-economic outcome respectively.
This is the first study to integrate multiple interventions for ulcer prevention into a personalized state-of-the-art treatment approach and assess their combined efficacy in a randomized controlled trial in people with diabetes at high ulcer risk. Proven effectiveness, usability, and cost-utility will facilitate implementation in healthcare, improve the quality of life of high-risk people with diabetes, and reduce treatment costs.
ClinicalTrials.gov NCT05236660. Registered on 11 February 2022.
预防糖尿病患者的足部溃疡可以提高生活质量并降低成本。尽管有各种预防足部溃疡的干预措施，但溃疡复发率仍然很高。我们假设，一种结合各种鞋类、自我管理和教育干预措施的多模式治疗方法，根据个体的需求进行匹配，可以降低溃疡复发的风险，同时具有良好的成本效益。本研究旨在评估针对高危糖尿病患者的综合个性化辅助设备方法对足部溃疡复发、鞋类使用依从性和成本效益的影响。
在一项平行组多中心随机对照试验中，将纳入 126 名成年 1 型或 2 型糖尿病患者，这些患者存在基于周围神经病变的保护性感觉丧失、在过去 4 年内有足底愈合性溃疡，以及拥有任何类型的定制鞋。参与者将被随机分配到增强治疗组或常规护理组。增强治疗组包括常规护理和个性化治疗方法，包括压力优化定制鞋、室内压力优化定制鞋、家庭日常足部温度监测以及结构化教育，包括动机性访谈和对依从性和自我护理的个性化反馈。参与者将接受 12 个月的随访。评估包括赤脚和穿鞋时的足底压力测量；关于生活质量、成本、疾病和自我护理知识的问卷；身体活动和鞋类使用监测；以及足部溃疡结果的临床监测。该研究的主要结果包括 3 个方面：足部溃疡复发、鞋类使用依从性和成本效益，分别为主要的临床、患者相关和健康经济学结果。
这是第一项将多种预防溃疡的干预措施整合到个性化的最先进治疗方法中，并在高溃疡风险的糖尿病患者中进行随机对照试验评估其联合疗效的研究。如果证明该方法有效、易用且具有成本效益，将有助于在医疗保健中实施，提高高危糖尿病患者的生活质量，并降低治疗成本。
ClinicalTrials.gov NCT05236660。于 2022 年 2 月 11 日注册。
