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Can 3D-Printed insoles beat milled ones for heel pain?

NCT ID NCT06563492

Symptom relief Sponsor: Medipol University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This trial tests two types of custom-made insoles for people with plantar fasciitis, a common cause of heel pain. One insole is milled from EVA foam, the other is 3D-printed from TPU plastic. Over 12 weeks, researchers measure calf muscle activity during walking, foot pressure, pain, and foot function to see if one insole offers better support. The study compares the two insole designs directly, rather than testing insoles against no treatment.

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: one type milled from EVA foam, the other 3D-printed from TPU plastic
What this could lead to
If one insole type works better, it could point toward a more effective, comfortable orthotic for plantar fasciitis, potentially easing heel pain and improving walking.
What could go wrong
This is a small, early trial with 41 participants, and it compares two active treatments rather than against a placebo, so it cannot prove insoles work overall. Results may not apply to everyone with plantar fasciitis.

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

41 people

The number who actually took part.

Started

Dec 2024

Finished

Jul 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

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: * Aged between 18 and 65 years * Clinical diagnosis of plantar fasciitis by a specialist physician * Clinical indication or prescription for custom-made foot orthoses * Plantar fasciitis symptoms lasting for at least 3 months * Heel pain localized to the plantar-medial calcaneal tubercle * First-step pain in the morning or pain during the first steps after a period of rest * Roles and Maudsley score of 3 or 4 at the baseline assessment * Ability and willingness to provide written informed consent and comply with the study procedures Exclusion Criteria: * Body mass index greater than 30 kg/m² * Presence of a clinically relevant cardiopulmonary, dermatological, neurological or musculoskeletal condition other than plantar fasciitis that could affect walking, plantar loading, pain assessment or participation in the study * History of foot or ankle surgery * Requirement for a walking assistive device during the study assessments * Inability or unwillingness to wear footwear compatible with the assigned foot orthoses * Cognitive or psychiatric condition that could prevent understanding of the study instructions, provision of informed consent or completion of the assessments * Pregnancy

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Conditions

The condition(s) this trial relates to.

plantar fasciitis

As listed by the trial registrant

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

Plantar fasciitis

Contacts and locations

Locations

  • Istanbul Medipol University, Prosthetics and Orthotics Center (POMER)

    Beykoz, Istanbul, 34815, Turkey (Türkiye)

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