Personalised Assistive Devices Approach for Diabetic Foot Ulcer Prevention
DIASSIST
Cost-utility of an Integrated Personalised Assistive Devices Approach to Reduce Foot Ulcer Recurrence in Diabetes (DIASSIST): a Multicentre Randomised Controlled Trial
1 other identifier
interventional
126
1 country
5
Brief Summary
Preventing foot ulcers in people with diabetes can reduce costs and increase quality of life. Despite availability of various interventions to prevent foot ulcers, recurrence rates remain high. We hypothesise that a multimodal approach incorporating a variety of orthotic interventions that matches an individual person's need can reduce ulcer recurrence with beneficial cost-effectiveness and cost-utility.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2022
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2022
CompletedFirst Posted
Study publicly available on registry
February 11, 2022
CompletedStudy Start
First participant enrolled
March 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 2, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 2, 2025
CompletedJanuary 6, 2026
January 1, 2026
3.6 years
January 17, 2022
January 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Cost-utility (as the primary economic outcome)
defined as the ratio between costs related to foot care and quality-adjusted life years, based on the health utilities associated with the scoring profiles on the EQ-5D-5L with Dutch reference scores
12 months (full study period)
Adherence to wearing custom-made footwear (as the primary patient-related outcome)
defined as the percentage of steps taken in prescribed footwear, calculated by combining physical activity and wearing time measurements
12 months (full study period)
Foot ulcer recurrence during the 12-months follow-up (as the primary clinical outcome)
defined as "a break of the skin of the foot that involves as a minimum the epidermis and part of the dermis, in a person who has a history of foot ulceration, irrespective of location and time since the previous foot ulcer", with the first ulcer in the study period recorded as primary outcome and percentage participants with ulcer recurrence on group level as primary outcome
12 months (full study period)
Secondary Outcomes (5)
Cost-effectiveness
12 months (full study period)
Plantar foot ulcer recurrence
12 months (full study period)
Foot ulcer recurrence at three predefined high-risk locations
12 months (full study period)
Costs related to foot care (from a societal and medical perspective)
12 months (full study period)
Quality-adjusted life years
12 months (full study period)
Study Arms (2)
Multimodal care
EXPERIMENTALMultimodal personalised treatment
Usual care
NO INTERVENTIONUsual care as offered to high-risk patients as offered in the Netherlands
Interventions
Pressure-optimized custom-made shoes: evaluated and optimized using in-shoe pressure analysis, and re-evaluated after 6 months.
Pressure-optimized custom-made indoor shoes: evaluated and optimized using in-shoe pressure analysis, and re-evaluated after 6 months. Specifically designed for indoor use.
Personalised patient education consisting of quantitative feedback on in-shoe pressures, temperature measurements and footwear use and, in addition, motivational interviewing where indicated and needed to improve device use.
Personalised at-home daily foot temperature monitoring at high-risk regions.
Eligibility Criteria
You may qualify if:
- Diabetes mellitus type 1 or 2
- Age 18 years or above
- Loss of protective sensation based on the presence of peripheral neuropathy
- In possession of custom-made orthopaedic shoes, defined as "Orthopaedic shoes type A" or "Orthopaedic shoes type B" , or Orthopaedic Provision in Regular Footwear (OVAC), according to the Dutch healthcare system
- Ability to provide informed consent
You may not qualify if:
- Foot ulcer or open amputation site(s)
- Active Charcot's neuroarthropathy
- Foot infection, based on criteria of the PEDIS classification
- Amputation proximal to the metatarsal bones in both feet
- Healed ulcer on the apex of digitus 2-5 as the only ulcer location in the past 4 years, as surgical intervention (flexor tenotomy) is a more likely and guideline-recommended treatment for such patients, rather than the multimodal care under investigation
- Severe illness that would make 12-months survival unlikely, based on the clinical judgment by the physician
- Concomitant severe physical or mental conditions that limit the ability to follow instructions for the study, based on clinical judgment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Amsterdam UMC
Amsterdam, Netherlands
Rode Kruis Ziekenhuis
Beverwijk, Netherlands
Reinier de Graaf Gasthuis
Delft, Netherlands
Spaarne Gasthuis
Hoofddorp, Netherlands
Máxima Medisch Centrum
Veldhoven, Netherlands
Related Publications (1)
Vossen LE, van Netten JJ, Bakker CD, Berendsen HA, Busch-Westbroek TE, Peters EJG, Sabelis LWE, Dijkgraaf MGW, Bus SA. 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. 2023 Oct 12;24(1):663. doi: 10.1186/s13063-023-07635-z.
PMID: 37828618DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sicco Bus, Prof
Amsterdam UMC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 17, 2022
First Posted
February 11, 2022
Study Start
March 2, 2022
Primary Completion
October 2, 2025
Study Completion
October 2, 2025
Last Updated
January 6, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- 2 years after study completion and for 15 years
- Access Criteria
- to be determined
Data can be made available after an embargo period, to allow the research team to write all prespecified publications. The embargo period is required, as publications may often follow once the project has already ended. The embargo period will be a maximum 2 years, to allow the research sufficient time to finish the publications as specified in the protocol. If publications are available earlier, the embargo will end earlier. Conditions for reuse will apply, but have yet to be finalized.