Personalised Assistive Devices Approach for Diabetic Foot Ulcer Prevention

Diabetic Foot Ulcer Clinical Trial

— DIASSIST  

Official title:

Cost-utility of an Integrated Personalised Assistive Devices Approach to Reduce Foot Ulcer Recurrence in Diabetes (DIASSIST): a Multicentre Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05236660
• Other study ID #: NL78943.018.21
• Status: Recruiting
• Phase: N/A
• Start date: March 2, 2022
• Est. completion date: July 2025

Study information

• Verified date: January 2024
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Lisa Vossen
• Phone: +31683511105
• Email: l.e.vossen[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

Device:
• Custom-made shoes: pressure-optimized
Pressure-optimized custom-made shoes: evaluated and optimized using in-shoe pressure analysis, and re-evaluated after 6 months.
• Custom-made indoor shoes: pressure optimized
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.
• Foot temperature monitoring
Personalised at-home daily foot temperature monitoring at high-risk regions.

Behavioral:
• Education
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.

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC	Amsterdam
Netherlands	Reinier de Graaf Gasthuis	Delft
Netherlands	Máxima Medisch Centrum	Veldhoven

Sponsors (2)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	Cost-effectiveness	defined as the ratio between costs related to foot care and foot ulcer recurrence on any location of the foot	12 months (full study period)
Secondary	Plantar foot ulcer recurrence	following the definition of foot ulcer recurrence (outcome 3), but then limited to the plantar side of the foot	12 months (full study period)
Secondary	Foot ulcer recurrence at three predefined high-risk locations	following the definition of foot ulcer recurrence (outcome 3), but then limited to a maximum 3 high risk locations per participant, specified at the start of the study, based on barefoot pressures, ulcer history, pre-ulcerative lesions or signs of abundant callus	12 months (full study period)
Secondary	Costs related to foot care (from a societal and medical perspective)	Costs will be calculated for each participant as the product sum of resource volume data and their respective unit costs. Resource volume data will be obtained from the completed study specific versions of the institute for Medical Technology Assessment (iMTA) Medical Consumption Questionnaire (iMCQ) and iMTA Productivity Cost Questionnaire (iPCQ), as these contain the volume data on healthcare resource utilization, out-of-pocket expenses and loss of productivity related to foot care. Foot care includes both care for ulcer prevention (e.g. podiatry appointments, rehabilitation physician consultations) and for ulcer treatment (e.g. multidisciplinary treatment, hospitalization, surgery). Reference prices for unit costs will be based on the most recent Dutch manual for costing in healthcare research available at the time of analysis. All costs will be summed during the entire study period.	12 months (full study period)
Secondary	Quality-adjusted life years	based on the health utilities associated with the scoring profiles on the EQ-5D-5L with Dutch reference scores. This will be monitored during the entire study period.	12 months (full study period)