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X-Ray vision for better prosthetic fit: inside the socket

NCT ID NCT05287646

Knowledge-focused 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is using a special X-ray technique (dynamic stereo X-ray) to see exactly how the bone and skin of a residual limb move inside a prosthetic socket. Researchers will compare two suspension methods—suction and elevated vacuum—in 21 people with below-knee amputations. The goal is to understand what causes poor fit, which can lead to pain and skin issues, and to guide better prosthetic design.

What this could mean

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

What this could lead to
If successful, this research could provide critical data to improve prosthetic socket design, reducing pain and skin problems for amputees.
What could go wrong
This is a small, early-stage observational study (21 participants) focused on measurement, not treatment. Results may not apply to all amputees or lead directly to better prosthetics.

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 21 people

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

Started

Jan 2024

Expected to finish

Mar 2027

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

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 (any etiology) * At least 18 years old * At least 6-months post-amputation * Current prosthetic users (at least 6 hours/day) Exclusion Criteria: * Unable to ambulate on a treadmill at low to moderate speed * Inability to tolerate the socket suspensions * Length of the residual limb prohibits socket fitting, dynamic stereo x-ray data capture, or marker placement * Mental impairment that impedes study compliance * Skin conditions (i.e. burns or poor skin coverage) as well as those with severe contractures that prevent prior prosthetic wear * Severe neuropathy, uncontrolled diabetes, have insensate foot, severe phantom pain, or a significant history of skin ulcers * Any other significant comorbidity that would interfere with the study * Severe circulatory problems including peripheral vascular disease and pitting edema * Cognitive deficits or mental health problems that would limit ability to participate fully in the study protocol * Women who are pregnant or who plan to become pregnant during the study

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As listed by the trial registrant

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

Amputation, lower limb

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

  • VA NY Harbor Healthcare System, New York, NY

    RECRUITING

    New York, New York, 10010-5011, United States

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