TY - JOUR
T1 - An integrated personalized assistive devices approach to reduce the risk of foot ulcer recurrence in diabetes (DIASSIST)
T2 - study protocol for a multicenter randomized controlled trial
AU - Vossen, Lisa E.
AU - van Netten, Jaap J.
AU - Bakker, Chantal D.
AU - Berendsen, Heleen A.
AU - Busch-Westbroek, Tessa E.
AU - Peters, Edgar J. G.
AU - Sabelis, Louise W. E.
AU - Dijkgraaf, Marcel G. W.
AU - Bus, Sicco A.
N1 - Funding Information: The DIASSIST trial is funded by ZonMw (the Netherlands Organization for Health Research and Development, project nr. 853001116) and co-funded by OFOM (the Dutch Foundation for the Development of Orthopedic Footwear) to investigate sub-questions in the field of shoe technology. The funders had no influence on the study design; the collection, management, analysis, and interpretation of data; the writing of the report; and the decision to submit the report for publication and had no ultimate authority over any of these activities. Publisher Copyright: © 2023, BioMed Central Ltd., part of Springer Nature.
PY - 2023/12/1
Y1 - 2023/12/1
N2 - Background: 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. Methods: 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. Discussion: 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. Trial registration: ClinicalTrials.gov NCT05236660. Registered on 11 February 2022.
AB - Background: 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. Methods: 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. Discussion: 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. Trial registration: ClinicalTrials.gov NCT05236660. Registered on 11 February 2022.
KW - Adherence
KW - Assistive devices
KW - Cost–benefit analysis
KW - Diabetic foot ulcer
KW - Education
KW - Footwear
KW - Motivational interviewing
KW - Personalized medicine
KW - Prevention
KW - Temperature monitoring
UR - http://www.scopus.com/inward/record.url?scp=85174002595&partnerID=8YFLogxK
U2 - https://doi.org/10.1186/s13063-023-07635-z
DO - https://doi.org/10.1186/s13063-023-07635-z
M3 - Article
C2 - 37828618
SN - 1745-6215
VL - 24
JO - Trials
JF - Trials
IS - 1
M1 - 663
ER -