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Study tests best prosthetic foot stiffness for amputees

NCT ID NCT07263945

Knowledge-focused Sponsor: University of Colorado, Denver Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at how the stiffness of a prosthetic foot affects people who have a leg amputation below the knee and use a bone-anchored limb or a standard socket. Researchers will measure bone stress, walking ability, pain, and fall risk as participants walk on different types of prosthetic feet. The goal is to find the best foot stiffness to improve safety and function.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 60 people

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

Started

Nov 2025

Expected to finish

May 2030

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

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: * Unilateral transtibial amputation due to traumatic, congenital, or cancer-related causes * \> 12-months bone-anchored limb implantation surgery (Bone Anchored Limb group) * \> 12-months limb amputation (Socket Control group) * Non-vascular amputation etiology * Low profile prosthetic foot (nominal) * Can walk unassisted for 5-minutes * \> 18 years old Exclusion Criteria: * Major amputation on contralateral limb * Vascular amputation etiology * Neurologic pathology that impairs coordination/balance * Regular assistive device use required for community ambulation * Inflammatory diseases or diabetes * Pregnancy or breastfeeding

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As listed by the trial registrant

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

Amputation Bone anchored devices Osseointegration Transtibial amputation - unilateral

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Colorado, Anschutz Medical Campus

    RECRUITING

    Aurora, Colorado, 80045-2559, United States

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