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Custom 3D printed insoles may help diabetic patients avoid foot ulcers

NCT ID NCT07641764

Symptom relief Sponsor: University of Faisalabad 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether 3D printed custom insoles are better than regular ready-to-wear insoles at reducing foot pressure in people with diabetic neuropathy. High foot pressure can lead to ulcers and mobility problems. Twenty-two adults with diabetes and nerve damage will be randomly assigned to one of two insole groups, and their foot pressure will be measured over 8 weeks.

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

About 22 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Jul 2026

An estimate. End dates often move.

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

35 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: * Age 35 to 65 years * Diagnosed with diabetes mellitus * Clinical diagnosis of diabetic peripheral neuropathy * Ability to walk independently without walking aids * Normal cognitive function * Corrected or uncorrected vision sufficient for safe ambulation * Willingness to provide written informed consent Exclusion Criteria: * Presence of active foot ulcer * External wound on lower extremity * History of lower limb surgery within past 6 months * Major lower limb amputation * Foot drop * Peripheral vascular disease * Neuromuscular diseases (e.g., stroke, Parkinson's disease, multiple sclerosis) * Charcot arthropathy * Inability to comply with study protocol

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Conditions

The condition(s) this trial relates to.

Diabetic Foot diabetic neuropathy

As listed by the trial registrant

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

Diabetic foot Diabetic neuropathies

Contacts and locations

Locations

  • The University of Faisalabad

    Faisalābad, Punjab Province, 3800, Pakistan

More trials for these conditions

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