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3D printed insoles aim to prevent diabetic foot ulcers

NCT ID NCT05301478

Symptom relief Sponsor: VA Office of Research and Development 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested custom 3D printed insoles for people with diabetes who are at risk of foot ulcers. Thirty participants wore different types of insoles in a lab to see which ones best reduced pressure on the bottom of the feet. The goal was to improve foot health and mobility.

What this could mean

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

Active substance
3D printed custom foot orthotics (insoles)
What this could lead to
If successful, these insoles could help prevent foot ulcers and improve mobility in people with diabetes.
What could go wrong
This was a small, early-stage study with only 30 participants, so results may not apply to everyone. The insoles were tested in a lab, not in daily life.

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

30 people

The number who actually took part.

Started

Mar 2022

Finished

Dec 2025

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

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 18+ years * Valid prescription for diabetic custom foot orthotics or current diabetic CFO user * Plantar pressure greater than or equal to250 KPa (assessed at first study visit) Exclusion Criteria: * Healed or non-healed foot ulcer within the last month * Prior amputation of more than 1 digit * Requirement for boots, custom shoes, or other specialty footwear for daily activities * Non-ambulatory status * Terminal illness that would make two-year survival unlikely * Pregnant (determined by self-report) * Inadequate cognitive function or language proficiency to consent to participate

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Conditions

The condition(s) this trial relates to.

diabetes mellitus

As listed by the trial registrant

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

Diabetes

Contacts and locations

Locations

  • VA Puget Sound Health Care System Seattle Division, Seattle, WA

    Seattle, Washington, 98108-1532, United States

More trials for these conditions

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