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NCT06458426

Thermoregulation in Individuals With a Leg Amputation

Enrolling by Invitation
NAAges 19+InterventionalBasic science
University of Utah
~60 participants
Updated 2026-05-14 on ClinicalTrials.gov
What's tested:shock-absorbing prosthesis

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Walking mechanics
Measured over during the intervention/procedure/surgery
+4 more outcomes measured

Conditions

Amputation
Diabetes

Explore related trials

Diabetes MellitusUnilateral Transtibial Amputation

Where it's being run

1 sites across 1 states
Utah1

Study leadership

  • Kota Takahashi · PRINCIPAL_INVESTIGATOR · University of Utah

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Individuals with a unilateral transtibial amputation, divided into two groups (with and without diabetes)
Participants must classify as Medicare class K2 or higher (who can traverse low-level environmental barriers such as curbs, stairs or uneven surfaces).
Participants must have undergone amputation at least 6 months prior.
They must have the ability to walk for at least 10 continuous minutes without undue fatigue.

Exclusion

Neurological impairment that may affect walking function, such as stroke, severe traumatic brain injury, Parkinson's disease, and multiple sclerosis.
History of inflammatory diseases, such as Raynaud's syndrome or rheumatoid arthritis.

What this trial measures

  • Walking mechanicsduring the intervention/procedure/surgery

    Mechanics of walking will be collected using a high-speed motion capture system and force-sensing platforms, which will quantify the motion of the legs and forces acting on the legs, respectively.

  • Vascular physiology - macrocirculationduring the intervention/procedure/surgery

    Macrocirculation of the legs (i.e.,blood flow) will be recorded using a Doppler ultrasound probe secured over the thigh during walking

  • Vascular physiology - microcirculationduring the intervention/procedure/surgery

    Microcirculation of the legs (i.e.,oxygen utility) will be recorded using near-infrared spectroscopy sensors placed on the thighs, calf, and top surface of the foot.

  • Temperature in lower limbduring the intervention/procedure/surgery

    Temperatures of the skin above the amputation site and the opposite intact foot will be recorded using thermistors and a thermal imaging camera.

  • Comfortduring the intervention/procedure/surgery

    Participants will complete a self-reported questionnaire to indicate comfort while walking with a prosthesis.