'diabetic foot' 'foot ulcers'
Conditions
Interventions
The treatment of participants who are randomized to multimodal care will
consist of usual care, and in addition a personalised state-of-the-art
multimodal orthotic treatment approach that contains:
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Diabetes mellitus type 1 or 2 2. Age 18 years or above 3. Loss of protective sensation based on the presence of peripheral neuropathy 4. A healed plantar foot ulcer or foot amputation in the preceding 4 years until two weeks before study inclusion 5. 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 6. Ability to provide informed consent
Exclusion criteria
Exclusion criteria: 1. Foot ulcer or open amputation site(s) 2. Active Charcot*s neuroarthropathy 3. Foot infection, based on criteria of the PEDIS classification 4. Amputation proximal to the metatarsal bones in both feet 5. 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 6. Severe illness that would make 12-months survival unlikely, based on the clinical judgment by the physician 7. Concomitant severe physical or mental conditions that limit the ability to follow instructions for the study, based on the clinical judgment by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| There are three main study parameters: • Cost-utility (as the primary economic outcome), defined as the ratio between costs related to foot care and quality-adjusted life year, based on the health utilities associated with the scoring profiles on the EQ-5D-5L with Dutch reference scores. • Adherence to wearing custom-made footwear (as the primary patient-related outcome), defined as the percentage of steps taken in appropriate, calculated by combining physical activity and wearing time measurements. • 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*. | — |
Secondary
| Measure | Time frame |
|---|---|
| Major secondary study parameters: • Cost-effectiveness, defined as the ratio between costs related to foot care and foot ulcer recurrence on any location of the foot, as defined at the primary study parameters. • Plantar foot ulcer recurrence, following the definition of foot ulcer recurrence in the primary study parameters section, only limited to the plantar area of the foot. • Foot ulcer recurrence at the three predefined high-risk locations (see treatment section 5.2.3 in the protocol), following the definition of foot ulcer recurrence in the primary study parameters section, only limited to the before mentioned high risk locations. • 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. • 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. Minor secondary study parameters: • Ulcer-free survival days in 12 months time (defined in accordance with Van Netten et al) • Time to ulceration • Cumula | — |
Countries
Netherlands
Outcome results
None listed