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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multimodal care | Experimental | Multimodal personalised treatment |
|
| Usual care | No Intervention | Usual care as offered to high-risk patients as offered in the Netherlands |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Plantar foot ulcer recurrence | following the definition of foot ulcer recurrence (outcome 3), but then limited to the plantar side of the foot |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sicco Bus, Prof | Amsterdam UMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC | Amsterdam | Netherlands | ||||
| Rode Kruis Ziekenhuis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37828618 | Derived | 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. |
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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.
2 years after study completion and for 15 years
to be determined
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| 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. |
|
| 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 | 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. | 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. | 12 months (full study period) |
| Beverwijk |
| Netherlands |
| Reinier de Graaf Gasthuis | Delft | Netherlands |
| Spaarne Gasthuis | Hoofddorp | Netherlands |
| Máxima Medisch Centrum | Veldhoven | Netherlands |
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D003920 | Diabetes Mellitus |
| D016523 | Foot Ulcer |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D005534 | Foot Diseases |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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