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Diabetic Foot UlcerDIASSISTNCT05236660

Personalised Assistive Devices Approach for Diabetic Foot Ulcer Prevention

A study testing Custom-made shoes: pressure-optimized, Custom-made indoor shoes: pressure optimized and Foot temperature monitoring in people with Diabetic Foot Ulcer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 5 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Foot Ulcer
What is being tested?
Custom-made shoes: pressure-optimized, Custom-made indoor shoes: pressure optimized and Foot temperature monitoring
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
5 sitesNetherlands
Study dates
2 Mar 2022to 30 Mar 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 join

  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Netherlands5 sites

  • Amsterdam UMC

    Amsterdam

  • Rode Kruis Ziekenhuis

    Beverwijk

  • Reinier de Graaf Gasthuis

    Delft

  • Spaarne Gasthuis

    Hoofddorp

  • Máxima Medisch Centrum

    Veldhoven

Other trials in Netherlands

About this study

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

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.

Being tested
Custom-made shoes: pressure-optimized, Custom-made indoor shoes: pressure optimized, Foot temperature monitoring, Education
Keywords
diabetes, foot ulcer, prevention, cost-utility
Medical subject headings
Diabetic Foot, Diabetes Mellitus, Foot Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Custom-made shoes: pressure-optimizedDevice

    Pressure-optimized custom-made shoes: evaluated and optimized using in-shoe pressure analysis, and re-evaluated after 6 months.

  • Custom-made indoor shoes: pressure optimizedDevice

    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 monitoringDevice

    Personalised at-home daily foot temperature monitoring at high-risk regions.

  • EducationBehavioural

    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.

Study groups in NCT05236660
Study groupRoleWhat they receive
Multimodal careExperimentalMultimodal personalised treatment
Receives: Device: Custom-made shoes: pressure-optimized; Device: Custom-made indoor shoes: pressure optimized; Device: Foot temperature monitoring; Behavioral: Education
Usual careNo interventionUsual care as offered to high-risk patients as offered in the Netherlands

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 months (full study period)

  2. 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

    Measured: 12 months (full study period)

  3. 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

    Measured: 12 months (full study period)

Secondary outcomes (5)

  1. Cost-effectiveness

    defined as the ratio between costs related to foot care and foot ulcer recurrence on any location of the foot

    Measured: 12 months (full study period)

  2. Plantar foot ulcer recurrence

    following the definition of foot ulcer recurrence (outcome 3), but then limited to the plantar side of the foot

    Measured: 12 months (full study period)

  3. 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

    Measured: 12 months (full study period)

  4. 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.

    Measured: 12 months (full study period)

  5. 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.

    Measured: 12 months (full study period)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2022
  2. Study start2 Mar 2022
  3. Primary completion2 Oct 2025
  4. Study completion30 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05236660
Sponsor's protocol ID
NL78943.018.21
Acronym
DIASSIST
Status last verified
May 2026
First submitted
17 Jan 2022
Last updated
14 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 37828618

Questions about this trial

What is this clinical trial studying?

A study testing Custom-made shoes: pressure-optimized, Custom-made indoor shoes: pressure optimized and Foot temperature monitoring in people with Diabetic Foot Ulcer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 5 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cost-utility (as the primary economic outcome) (time frame: 12 months (full study period)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05236660, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.

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