AI-Powered Research

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>There are three main study parameters:<br /><br>• Cost-utility (as the primary economic outcome), defined as the ratio between<br /><br>costs related to foot care and quality-adjusted life year, based on the health<br /><br>utilities associated with the scoring profiles on the EQ-5D-5L with Dutch<br /><br>reference scores.<br /><br>• Adherence to wearing custom-made footwear (as the primary patient-related<br /><br>outcome), defined as the percentage of steps taken in appropriate, calculated<br /><br>by combining physical activity and wearing time measurements.<br /><br>• Foot ulcer recurrence during the 12-months follow-up (as the primary clinical<br /><br>outcome), defined as a break of the skin of the foot that involves as a<br /><br>minimum the epidermis and part of the dermis, in a person who has a history of<br /><br>foot ulceration, irrespective of location and time since the previous foot<br /><br>ulcer. </p><br>

Secondary Outcome Measures