Personalised Assistive Devices Approach for Diabetic Foot Ulcer Prevention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-02

Study Completion Date

2025-10-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetic Foot Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Multimodal care

Multimodal personalised treatment

Group Type EXPERIMENTAL

Custom-made shoes: pressure-optimized

Intervention Type DEVICE

Pressure-optimized custom-made shoes: evaluated and optimized using in-shoe pressure analysis, and re-evaluated after 6 months.

Custom-made indoor shoes: pressure optimized

Intervention Type DEVICE

Pressure-optimized custom-made indoor shoes: evaluated and optimized using in-shoe pressure analysis, and re-evaluated after 6 months. Specifically designed for indoor use.

Foot temperature monitoring

Intervention Type DEVICE

Personalised at-home daily foot temperature monitoring at high-risk regions.

Education

Intervention Type BEHAVIORAL

Personalised patient education consisting of quantitative feedback on in-shoe pressures, temperature measurements and footwear use and, in addition, motivational interviewing where indicated and needed to improve device use.

Usual care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Custom-made shoes: pressure-optimized

Pressure-optimized custom-made shoes: evaluated and optimized using in-shoe pressure analysis, and re-evaluated after 6 months.

Intervention Type DEVICE

Custom-made indoor shoes: pressure optimized

Pressure-optimized custom-made indoor shoes: evaluated and optimized using in-shoe pressure analysis, and re-evaluated after 6 months. Specifically designed for indoor use.

Intervention Type DEVICE

Foot temperature monitoring

Personalised at-home daily foot temperature monitoring at high-risk regions.

Intervention Type DEVICE

Education

Personalised patient education consisting of quantitative feedback on in-shoe pressures, temperature measurements and footwear use and, in addition, motivational interviewing where indicated and needed to improve device use.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No