Thermoregulation in Individuals With a Leg Amputation

NCT06458426 | Enrolling By Invitation

• 1 other identifier: 00155345
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Amputation; Diabetes

Outcome Measures

Primary Outcomes (5)

• Walking mechanics

  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.

  during the intervention/procedure/surgery

• Vascular physiology - macrocirculation

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

  during the intervention/procedure/surgery

• Vascular physiology - microcirculation

  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.

  during the intervention/procedure/surgery

• Temperature in lower limb

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

  during the intervention/procedure/surgery

• Comfort

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

  during the intervention/procedure/surgery

Study Arms (2)

Rigid Pylon

EXPERIMENTAL

The prosthesis will be given a commercial prosthetic foot and a rigid pylon that connects the prosthetic foot to the socket.

Device: shock-absorbing prosthesis

Shock-absorbing Pylon

EXPERIMENTAL

The prosthesis will be given a commercial prosthetic foot and a compressive 'shock-absorbing' pylon that connects the prosthetic foot to the socket.

Device: shock-absorbing prosthesis

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.

Rigid Pylon; Shock-absorbing Pylon

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112-0920, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kota Takahashi

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 13, 2024
• Study Start: May 7, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)