Athletic shoe tech could revolutionize prosthetic arm sockets

NCT ID NCT05990062

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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 Results may not be published yet.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)
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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

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Status unknown
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First seen Jul 17, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This study tests a new type of prosthetic socket for people with below-elbow amputations. The K-Socket-Harness system uses a flexible, breathable design inspired by athletic shoes, aiming to be more comfortable and secure than standard hard sockets. Researchers will fit 25 veterans with the new socket and measure how well it holds up during tasks like rowing, as well as how easy it is to use.

What this could mean

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

Active substance
K-Socket-Harness (KSH) system, a hybrid polymer and textile-based prosthetic socket and harness
What this could lead to
If successful, this could lead to a more comfortable and functional prosthetic socket for people with below-elbow amputations, improving daily life and activity levels.
What could go wrong
This is an early-stage study with only 25 participants, so results may not apply to all amputees. The new socket might not be as durable or effective as standard options.

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

About 25 people

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

Started

Jun 2025

Expected to finish

Sep 2028

An estimate. End dates often move.

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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.

Inclusion Criteria: * Unilateral transradial arm amputation * Possession of a functioning and wearable previously fit prosthetic arm of any type * Residual limb length of at least 4 inches from the lateral epicondyle to the distal tip * Residual limb length less than or equal to that allowing a clearance of 1.5 inches from a fitted wrist * Must have at least 5-years of prosthetic use experience (For Phase 1 \& 2) * Must have at least 1-year of prosthetic use experience (For Phase 3 only) Exclusion Criteria: * Current open sores or incisions, Heterotopic ossification (HO), traumatic neuromas, or any other condition preventing the wearing of a prosthetic socket * Residual limb length less than 4 inches * Residual limb length greater than that allowing 1.5 inches clearance from a fitted wrist. The investigators will make every effort to recruit Veterans. If its found that it is not possible to recruit enough Veterans, the investigators will perform a non-Veteran amendment to this protocol.

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As listed by the trial registrant

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How to take part

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

    RECRUITING

    Pittsburgh, Pennsylvania, 15240, United States

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