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Why do prosthetic limbs feel so hot? new study investigates

NCT ID NCT07215442

Knowledge-focused Sponsor: VA Puget Sound Health Care System 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how people with below-knee amputations sense hot and cold on their skin and how their blood vessels react to temperature changes. Researchers tested 56 participants, including those with and without diabetes, to find the temperature thresholds where warmth or coolness is first noticed. The goal is to understand why prosthetic limbs often cause discomfort and to guide future designs for better temperature control.

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

56 people

The number who actually took part.

Started

Apr 2011

Finished

Aug 2013

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 to 70 years

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 for All Participants: * Able to ambulate without upper extremity aids * Able to attend study visits * Able to sense a Semmes-Weinstein 5.07 monofilament applied to proximal lateral aspect of test limb calf * Cognitively aware Additional Inclusion Criteria for Individuals with Lower Limb Amputation * Have been fit with a prosthesis * Have used a prosthesis for at least six months * Wear the prosthesis for at least four hours per day by self-report Exclusion Criteria for Individuals with Lower Limb Amputation: \- Have no residual limb ulcers

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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 (DM) Lower limb amputation below knee Skin temperature change Vascular reactivity

Contacts and locations

Locations

  • VA Puget Sound Health Care System Seattle Division

    Seattle, Washington, 98108, United States

More trials for these conditions

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