An interventional study of Custom-made shoes: pressure-optimized and Custom-made indoor shoes: pressure optimized in Diabetic Foot Ulcer, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Completed at 5 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Not applicable, Interventional, and 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.
1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's enrollment of 126 is above the median of 60 across 826 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 512 studies on the registry; 178 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Multimodal personalised treatment
Device: Custom-made shoes: pressure-optimized · Device: Custom-made indoor shoes: pressure optimized · Device: Foot temperature monitoring · Behavioral: Education
Usual care as offered to high-risk patients as offered in the Netherlands
Pressure-optimized custom-made shoes: evaluated and optimized using in-shoe pressure analysis, and re-evaluated after 6 months.
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.
Personalised at-home daily foot temperature monitoring at high-risk regions.
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.
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
Time frame: 12 months (full study period)
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
Time frame: 12 months (full study period)
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
Time frame: 12 months (full study period)
Cost-effectiveness
defined as the ratio between costs related to foot care and foot ulcer recurrence on any location of the foot
Time frame: 12 months (full study period)
Plantar foot ulcer recurrence
following the definition of foot ulcer recurrence (outcome 3), but then limited to the plantar side of the foot
Time frame: 12 months (full study period)
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
Time frame: 12 months (full study period)
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.
Time frame: 12 months (full study period)
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.
Time frame: 12 months (full study period)
Plan to share: 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.
Supporting information: Study protocol
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)