Personalised Assistive Devices Approach for Diabetic Foot Ulcer Prevention (DIASSIST)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status: Completed

Conditions: Diabetic Foot Ulcer

Treatments: Device: Foot temperature monitoring; Device: Custom-made shoes: pressure-optimized; Device: Custom-made indoor shoes: pressure optimized; Behavioral: Education

Study type: Interventional

Funder types: Other

Identifiers

NCT05236660

NL78943.018.21

Details and patient eligibility

About

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.

Enrollment: 126 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

Multimodal care

Experimental group

Description:

Multimodal personalised treatment

Treatment:

Behavioral: Education

Device: Custom-made indoor shoes: pressure optimized

Device: Custom-made shoes: pressure-optimized

Device: Foot temperature monitoring

Usual care

No Intervention group

Description:

Usual care as offered to high-risk patients as offered in the Netherlands