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Smart sock sensor could prevent amputee skin problems

NCT ID NCT07216183

Knowledge-focused Sponsor: North Carolina State University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early study tests a new sensor called E-SWEAT that fits inside a prosthetic leg socket. It measures sweat, pressure, and temperature to see how these factors affect skin health. Sixteen adults with below-knee amputations will wear the sensor while walking and doing a yoga pose. The goal is to see if the sensor works reliably and if higher pressure leads to more lactic acid in sweat.

What this could mean

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

Active substance
E-SWEAT sensor (a device that measures sweat lactic acid, pressure, and temperature inside the prosthetic socket)
What this could lead to
If successful, this sensor could help researchers and clinicians better understand how pressure and sweat affect skin health in amputees, potentially leading to improved socket designs.
What could go wrong
This is a very small, early feasibility study with only 16 participants. The sensor is new and may not work reliably, and the results may not apply to all amputees.

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 16 people

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

Started

Sep 2025

Expected to finish

Jul 2029

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 to 75 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: * Be 18 years or older * Have a unilateral lower limb amputee (below the knee). The tibial length on the residual limb must be greater than half of the length of the tibial on the unaffected side * Have an amputation that occurred over 2 years ago * Have at least 1 year of experience using your prosthetic leg * Have used the current socket for at least 6 months without a significant skin issue or major modification * Be able to comfortably walk 6 mins (with prosthetic legs) without pausing to rest * Be willing to come to North Carolina State University's Centennial Campus to participate in research and be photographed while doing research activities Exclusion Criteria: * Have a cognitive or visual impairment that affects the participant's ability to provide informed consent or to follow simple instructions during the experiments * Have any neuropathy observed on the residual limb * Experience numbness, tingling, muscle weakness, and/or pain in your residual limb * Weigh more than 300lbs * Do not want to take photos * Are pregnant or plan to get pregnant * Are allergic to latex, which is often contained in medical tapes. * If you are using medication to control sweat on your residual limb, and your medical provider does not think that it is OK to avoid these medications for 48 hours.

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Conditions

The condition(s) this trial relates to.

decubitus ulcer

As listed by the trial registrant

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

Transtibial amputation

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

  • Engineering Build III

    RECRUITING

    Raleigh, North Carolina, 27695, United States

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