Personalised Assistive Devices Approach for Diabetic Foot Ulcer Prevention

Cost-utility of an Integrated Personalised Assistive Devices Approach to Reduce Foot Ulcer Recurrence in Diabetes (DIASSIST): a Multicentre Randomised Controlled Trial

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.

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