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Shoe fit rules put to the test for diabetic foot health

NCT ID NCT06025422

Knowledge-focused Sponsor: University Hospitals, Leicester Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at how different shoe fit guidelines affect pressure inside the shoe for people with diabetes and nerve damage. Researchers measured foot pressure while 26 participants walked in standardized shoes with different toe gap sizes. The goal was to see which fit guideline best reduces pressure that can lead to foot ulcers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to better footwear recommendations to reduce foot ulcers in people with diabetes.
What could go wrong
This is a small pilot study with only 26 participants, so results may not apply to everyone. It measures pressure, not actual ulcer prevention.

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.

Participants

26 people

The number who actually took part.

Started

Dec 2022

Finished

Jun 2025

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.

Who is studied

Sixty people with diabetes type 1 or 2 and neuropathy aged between 18 and 80

Ages

18 to 80 years

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: * Men and women aged 18-80 years * Confirmed diagnosis of diabetes mellitus type 1 or type 2 * Confirmed diagnosis of neuropathy; * Able to walk unaided for a minimum of 200 steps with capacity to attend the research site * PAR-Q physical activity questionnaire does not indicate any possible heart problems, dizziness or other issue indicating unsuitability for mild physical exercise involved in walking * Willingness and capacity to participate in the study and to sign the informed consent form Exclusion Criteria: * Unconfirmed diabetes mellitus diagnosis * Inability to ambulate independently without walking aids * Presence of rheumatoid arthritis * Active ulcer (i.e. having an active ulcer at the time of recruitment) * Recently healed ulcer (an ulcer which has had less than six months to fully heal) * History of Charcot in foot/joints * Previous minor or major amputation * Neurological disorders other than diabetes-related neuropathy potentially affecting gait, balance or posture * Evidence of significant peripheral vascular disease e.g. (i) attendance at a specialist vascular clinic; (ii) documentation of occlusive arterial disease or intervention; (iii) at least one pulse should be palpable on the affected foot with exclusion where neither pulse is palpable * Blood pressure \>180/100 or \<90/50 * Unable to understand written and verbal English * PAR-Q physical activity questionnaire indicates possible heart problems, dizziness or other issue indicating unsuitability for mild physical exercise involved in walking

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Conditions

The condition(s) this trial relates to.

diabetes mellitus Diabetic Foot diabetic neuropathy

As listed by the trial registrant

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

Diabetic foot ulcer Diabetic neuropathies

Contacts and locations

Locations

  • Leicester Diabetes Centre

    Leicester, Leicestershire, LE5 4PW, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.