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Personalised Assistive Devices Approach for Diabetic Foot Ulcer Prevention

Key facts

Who runs it
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Where
Netherlands5 sites in 1 countryChoose a country to see its sites
Trial code
Status
Completed
People taking part
126 people enrolled
Started
2 Mar 2022
Ended
30 Mar 2026
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • Custom-made shoes: pressure-optimized
  • Custom-made indoor shoes: pressure optimized
  • Foot temperature monitoring
  • Education
Record updated
14 May 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Concomitant severe physical or mental conditions that limit the ability to follow instructions for the study, based on clinical judgment
  • Foot ulcer or open amputation site(s)
  • Foot infection, based on criteria of the PEDIS classification
  • 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
  • Active Charcot's neuroarthropathy
  • Amputation proximal to the metatarsal bones in both feet

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Multimodal careTreatment being tested

    Multimodal personalised treatment

    Treatment: Custom-made shoes: pressure-optimized, Custom-made indoor shoes: pressure optimized, Foot temperature monitoring, and Education

  • Usual careNo study treatment, for comparison

    Usual care as offered to high-risk patients as offered in the Netherlands

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Cost-utility of an Integrated Personalised Assistive Devices Approach to Reduce Foot Ulcer Recurrence in Diabetes (DIASSIST): a Multicentre Randomised Controlled Trial
Publications
Record updated
14 May 2026