Thermoregulation in Individuals With a Leg Amputation

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Utah
Study ID
NCT06458426
Status
Enrolling By Invitation

Conditions

  • Amputation
  • Diabetes

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • shock-absorbing prosthesis — DEVICE
    the intervention will test the difference between rigid and shock-absorbing pylons, while the same prosthetic foot is applied in each condition.

Study Details

The goal of this project is to understand the factors that affect skin temperature (e.g., tissue above amputation site, and opposite foot) in people with amputation and diabetes. This project will also test the effects of 'shock-absorbing' prosthesis on skin temperature responses.

Key Dates

Start date
May 7, 2024
Status verified
Aug 2025
Primary completion
Jul 1, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Rigid Pylon
    The prosthesis will be given a commercial prosthetic foot and a rigid pylon that connects the prosthetic foot to the socket.
  • Experimental: Shock-absorbing Pylon
    The prosthesis will be given a commercial prosthetic foot and a compressive 'shock-absorbing' pylon that connects the prosthetic foot to the socket.

Primary Outcome Measure

Walking mechanics [ Time Frame: during the intervention/procedure/surgery ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of UtahSalt Lake CityUtah84112-0920-

Find similar trials in Salt Lake City, UT

By research site
University of Utah· Salt Lake City, UT

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