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Specially designed insoles could help diabetic patients walk better

NCT ID NCT06846476

Symptom relief Sponsor: Medipol University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 30, 2026 · Updated 2 times

Summary

This study tested custom-made insoles for people with diabetic foot to see if they improve balance and walking. Twenty-five participants aged 40 to 65 with early-stage diabetic foot issues were included. The insoles were designed using pressure measurements to offload high-pressure areas. The study measured postural balance and walking efficiency.

What this could mean

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

Active substance
custom-made insoles
What this could lead to
If effective, these insoles could help people with diabetic foot feel steadier and walk more easily, reducing fall risk.
What could go wrong
This is a small, completed study with only 25 participants, so results may not apply to everyone. The insoles are not a treatment for the underlying disease.

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

25 people

The number who actually took part.

Started

Dec 2024

Finished

Aug 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.

Ages

40 to 65 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: * between the ages of 35 and 70, * Wagner Classification stages 0 or 1, * He has type I or type II diabetes, * No history of amputation surgery, * Individuals using shoes suitable for insoles will be included in the study. Exclusion Criteria: * \- Using an assistive device (long-walking device, walker, canadiene, etc.), * He has a history of amputation, * He has a Charcot foot deformity, * The one with the open wound, * Physical disability that may restrict joint movement, * Individuals using shoes that are not suitable for insoles will not be included in the study.

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Conditions

The condition(s) this trial relates to.

diabetes mellitus Diabetic Foot

As listed by the trial registrant

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

Diabetic foot ulcer (DFU) Orthoses Plantar pressure distrubution Postural balance

Contacts and locations

Locations

  • Istanbul Medipol University

    Istanbul, Istanbul, 34794, Turkey (Türkiye)

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