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Smart shoes aim to stop diabetic foot ulcers in their tracks

NCT ID NCT05236660

Disease control Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a personalized approach using custom-made shoes and inserts to prevent foot ulcers from returning in people with diabetes. 126 adults with a history of foot ulcers were followed for 12 months. The goal was to see if this tailored approach could reduce ulcer recurrence and be cost-effective.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

126 people

The number who actually took part.

Started

Mar 2022

Finished

Mar 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

diabetes mellitus Diabetic Foot Foot Ulcer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic foot ulcer

Contacts and locations

Locations

  • Amsterdam UMC

    Amsterdam, Netherlands

  • Máxima Medisch Centrum

    Veldhoven, Netherlands

  • Reinier de Graaf Gasthuis

    Delft, Netherlands

  • Rode Kruis Ziekenhuis

    Beverwijk, Netherlands

  • Spaarne Gasthuis

    Hoofddorp, Netherlands

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