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New prosthetic foot aims to improve comfort for amputees

NCT ID NCT06468059

Symptom relief Sponsor: Little Room Innovations, LLC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a new type of prosthetic foot designed for people with below-knee amputation who have longer residual limbs. The foot is low-profile but built to be both flexible and strong. Six participants walked with the new foot and their usual prescribed foot so researchers could compare how much energy the foot stores and how it moves. The goal was to see if this new design offers similar benefits to taller prosthetic feet.

What this could mean

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

Active substance
Layered Low Profile Foot (prosthetic device)
What this could lead to
If it works, this could lead to a more comfortable and efficient prosthetic foot for people with long residual limbs after below-knee amputation.
What could go wrong
This was a very small early study with only 6 participants, so results may not apply to everyone. The device is still experimental and not yet widely available.

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

6 people

The number who actually took part.

Started

Mar 2024

Finished

Jul 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 89 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: 1. 18-89 years old 2. unilateral transtibial amputation 3. daily use of a low profile foot 4. cognitive ability to understand and willingness to provide informed consent and follow the study protocol Exclusion Criteria: 1. unable to perform walking for 2 minutes without an assistive device 2. other health conditions which may prevent them from participating in the study

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As listed by the trial registrant

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

Amputation

Contacts and locations

Locations

  • Kennesaw State University

    Kennesaw, Georgia, 30144, United States

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