An integrated personalized assistive devices approach to reduce the risk of foot ulcer recurrence in diabetes (DIASSIST): study protocol for a multicenter randomized controlled trial

Trials

Study Protocol

Chantal D. Bakker¹  Heleen A. Berendsen²  Marcel G. W. Dijkgraaf³  Edgar J. G. Peters⁴  Louise W. E. Sabelis⁵  Lisa E. Vossen⁶  Jaap J. van Netten⁶  Sicco A. Bus⁶  Tessa E. Busch-Westbroek⁶ 

[1] Department of Rehabilitation Medicine, Máxima Medisch Centrum Veldhoven, de Run 4600, 5504 DB, Veldhoven, the Netherlands;Department of Rehabilitation Medicine, Reinier de Graaf Gasthuis Delft, Reinier de Graafweg 5, 2625 AD, Delft, the Netherlands;Epidemiology and Data Science, Amsterdam UMC Location University of Amsterdam, Meibergdreef 9, Amsterdam, the Netherlands;Methodology, Amsterdam Public Health, Meibergdreef 9, Amsterdam, the Netherlands;Rehabilitation & Development, Amsterdam Movement Sciences, Amsterdam, the Netherlands;Internal Medicine, Amsterdam UMC Location Vrije Universiteit Amsterdam, Boelelaan 1117, Amsterdam, the Netherlands;Rehabilitation & Development, Amsterdam Movement Sciences, Amsterdam, the Netherlands;Rehabilitation Medicine, Amsterdam UMC Location Vrije Universiteit Amsterdam, Boelelaan 1117, Amsterdam, the Netherlands;Rehabilitation Medicine, Amsterdam UMC Location University of Amsterdam, Meibergdreef 9, Amsterdam, the Netherlands;Rehabilitation & Development, Amsterdam Movement Sciences, Amsterdam, the Netherlands;

关键词: Diabetic foot ulcer;    Prevention;    Cost–benefit analysis;    Adherence;    Personalized medicine;    Footwear;    Assistive devices;    Temperature monitoring;    Education;    Motivational interviewing;   

DOI  :  10.1186/s13063-023-07635-z

 received in 2023-07-04, accepted in 2023-09-08,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundPreventing 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.MethodsIn 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.DiscussionThis 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.Trial registrationClinicalTrials.gov NCT05236660. Registered on 11 February 2022.

【 授权许可】

CC BY   
© BioMed Central Ltd., part of Springer Nature 2023

【 图 表 】

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Fig. 9