Clinical trial NCT05236660: Personalised Assistive Devices Approach for Diabetic Foot Ulcer Prevention
Official title: Cost-utility of an Integrated Personalised Assistive Devices Approach to Reduce Foot Ulcer Recurrence in Diabetes (DIASSIST): a Multicentre Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetic Foot Ulcer
Keywords: diabetes
foot ulcer
prevention
cost-utility
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2022-02-11
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* Diabetes mellitus type 1 or 2
* Age 18 years or above
* Loss of protective sensation based on the presence of peripheral neuropathy
* A healed plantar foot ulcer or foot amputation in the preceding 4 years until two weeks before study inclusion
* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Cost-utility (as the primary economic outcome)
timeFrame: 12 months (full study period)
measure: Adherence to wearing custom-made footwear (as the primary patient-related outcome)
timeFrame: 12 months (full study period)
measure: Foot ulcer recurrence during the 12-months follow-up (as the primary clinical outcome)
timeFrame: 12 months (full study period)
Secondary outcomes:
measure: Cost-effectiveness
timeFrame: 12 months (full study period)
measure: Plantar foot ulcer recurrence
timeFrame: 12 months (full study period)
measure: Foot ulcer recurrence at three predefined high-risk locations
timeFrame: 12 months (full study period)
measure: Costs related to foot care (from a societal and medical perspective)
timeFrame: 12 months (full study period)
measure: Quality-adjusted life years
timeFrame: 12 months (full study period)
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
city: Beverwijk
country: Netherlands
facility: Rode Kruis Ziekenhuis
city: Delft
country: Netherlands
facility: Reinier de Graaf Gasthuis
city: Hoofddorp
country: Netherlands
facility: Spaarne Gasthuis
city: Veldhoven
country: Netherlands
facility: Máxima Medisch Centrum
Study officials:
affiliation: Amsterdam UMC
name: Sicco Bus, Prof
role: PRINCIPAL_INVESTIGATOR
References: