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Can 3D-Printed insoles take the pressure off diabetic feet?

NCT ID NCT07781618

Knowledge-focused Sponsor: Universitaire Ziekenhuizen KU Leuven 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time

Summary

This study explores whether a portable 3D scanner can reliably measure foot shape and whether custom 3D-printed insoles can reduce pressure on the ball of the foot in healthy adults. Participants will have their feet scanned and tested with several insole designs to see which provides the best pressure relief. The goal is to improve the design of foot orthotics, which could one day help prevent foot ulcers in people with diabetes.

What this could mean

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

Active substance
Customized 3D-printed foot orthotics (insoles)
What this could lead to
If successful, this could lead to more precise, personalized insoles that better prevent foot ulcers in people with diabetes.
What could go wrong
This is a small, early study in healthy adults, so results may not apply to people with diabetes or other conditions. The insoles may not provide the expected pressure relief.

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

33 people

The number who actually took part.

Started

Oct 2023

Finished

Aug 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 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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.

Reliability study: The inclusion criteria: • Healthy population, age 18-65-year-old The exclusion criteria: * No injury of trauma of the lower limb in the past 6 months * No surgical procedures of the lower limbs or back in the past 6 months * Not pregnant at the time of testing * No (auto) immune system disorders with a possible impact on the feet (e.g., rheumatoid arthritis) * No systemic or neurological disorder Interventional study The inclusion criteria: * Healthy population, age 18-65-year-old * Maximum weight of 90 kg * In-shoe M2 - M3 or central pattern bilateral or left/right The exclusion criteria: * No injury of trauma of the lower limb in the past 6 months * No surgical procedures of the lower limbs or back in the past 6 months * Not pregnant at the time of testing * No (auto) immune system disorders with a possible impact on the feet (e.g., rheumatoid arthritis) * No systemic or neurological disorder * Work does not require wearing safety shoes

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As listed by the trial registrant

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

Healthy

Contacts and locations

Locations

  • KU Leuven Campus Bruges

    Bruges, West-Flanders, 8200, Belgium

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