Skip to main content
OpenTrials
Completed

NCT Number: NCT05236660

Personalised Assistive Devices Approach for Diabetic Foot Ulcer Prevention

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetic Foot Ulcer Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Diseases Foot Ulcer Glucose Metabolism Disorders Leg Ulcer Metabolic Diseases Nutritional and Metabolic Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amsterdam UMC, Amsterdam, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Custom-made shoes: pressure-optimized

Device

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

Device

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

Device

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

Education

Behavioral

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.

Primary outcomes

  1. Cost-utility (as the primary economic outcome)

    Time frame: 12 months (full study period)

    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

  2. Adherence to wearing custom-made footwear (as the primary patient-related outcome)

    Time frame: 12 months (full study period)

    defined as the percentage of steps taken in prescribed footwear, calculated by combining physical activity and wearing time measurements

  3. Foot ulcer recurrence during the 12-months follow-up (as the primary clinical outcome)

    Time frame: 12 months (full study period)

    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

Secondary outcomes

  1. Cost-effectiveness

    Time frame: 12 months (full study period)

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

  2. Plantar foot ulcer recurrence

    Time frame: 12 months (full study period)

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

  3. Foot ulcer recurrence at three predefined high-risk locations

    Time frame: 12 months (full study period)

    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

  4. Costs related to foot care (from a societal and medical perspective)

    Time frame: 12 months (full study period)

    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.

  5. Quality-adjusted life years

    Time frame: 12 months (full study period)

    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.

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

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

Acronym: DIASSIST

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Feb 11, 2022
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.