Clinical Research Directory

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