Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2025-12-17 @ 12:31 AM
Study NCT ID:
NCT06458426
Status:
None
Last Update Posted:
2024-06-13 00:00:00
First Post:
2024-06-06 00:00:00
Brief Title:
Thermoregulation in Individuals With a Leg Amputation
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
Thermoregulation in Individuals With a Leg Amputation: Mechanics and Vascular Physiology Factors to Understand Risks for Tissue Complications
Status:
None
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overall goal of this project is to understand the factors that affect impaired temperature control in individuals with a leg amputation for areas vulnerable to damage, such as the tissue above the amputation site and the opposite intact foot. Abnormal tissue temperature is associated with risks for tissue damage, such as ulcers and pressure sores, especially in people with diabetes. In this study, we aim to study the effects of biomechanics and vascular physiology on tissue temperature responses. We will also determine the effectiveness of prosthetic shock-absorbing components in protecting the tissue from damage.
It is hypothesized that the temperatures of tissues above the amputation site and in the opposite intact foot are associated with mechanical factors during walking, such as shear forces and work (i.e., energy). It is also hypothesized that impaired temperature regulation, especially in people with diabetes, is associated with poor vascular function that inhibits effective blood circulation and oxygen delivery to affected tissues. Lastly, it is hypothesized that walking with a shock-absorbing prosthetic component can improve comfort and improve temperature regulation of tissues above the amputation site.
This project will recruit 40 individuals with a unilateral transtibial (below-knee) amputation, divided into two groups: with and without diabetes. All individuals will be given two sets of prostheses: with and without a shock-absorbing pylon (SAP). SAP is a modular prosthetic component that connects the socket and the foot components and allows added compression and twisting along the pylon. In both sets of prostheses conditions, the participants will wear the same foot component provided by the research team. For each of the two sets of prostheses (with and without SAP), the participants will make up to 5 visits to the laboratory (i.e., up to 10 total visits for the entire protocol). Each visit will involve data collections under a variety of walking tasks, such as walking on various slopes and turning. The same data collections will be repeated with the other set of prostheses.
It is hypothesized that the temperatures of tissues above the amputation site and in the opposite intact foot are associated with mechanical factors during walking, such as shear forces and work (i.e., energy). It is also hypothesized that impaired temperature regulation, especially in people with diabetes, is associated with poor vascular function that inhibits effective blood circulation and oxygen delivery to affected tissues. Lastly, it is hypothesized that walking with a shock-absorbing prosthetic component can improve comfort and improve temperature regulation of tissues above the amputation site.
This project will recruit 40 individuals with a unilateral transtibial (below-knee) amputation, divided into two groups: with and without diabetes. All individuals will be given two sets of prostheses: with and without a shock-absorbing pylon (SAP). SAP is a modular prosthetic component that connects the socket and the foot components and allows added compression and twisting along the pylon. In both sets of prostheses conditions, the participants will wear the same foot component provided by the research team. For each of the two sets of prostheses (with and without SAP), the participants will make up to 5 visits to the laboratory (i.e., up to 10 total visits for the entire protocol). Each visit will involve data collections under a variety of walking tasks, such as walking on various slopes and turning. The same data collections will be repeated with the other set of prostheses.
Detailed Description:
The overall goal of this project is to understand the factors that affect impaired temperature control in individuals with a leg amputation for areas vulnerable to damage such as the tissue above the amputation site and the opposite intact foot Abnormal tissue temperature is associated with risks for tissue damage such as ulcers and pressure sores especially in people with diabetes In this study we aim to study the effects of biomechanics and vascular physiology on tissue temperature responses We will also determine the effectiveness of prosthetic shock-absorbing components in protecting the tissue from damage
It is hypothesized that the temperatures of tissues above the amputation site and in the opposite intact foot are associated with mechanical factors during walking such as shear forces and work ie energy It is also hypothesized that impaired temperature regulation especially in people with diabetes is associated with poor vascular function that inhibits effective blood circulation and oxygen delivery to affected tissues Lastly it is hypothesized that walking with a shock-absorbing prosthetic component can improve comfort and improve temperature regulation of tissues above the amputation site
This project will recruit 40 individuals with a unilateral transtibial below-knee amputation divided into two groups with and without diabetes All individuals will be given two sets of prostheses with and without a shock-absorbing pylon SAP SAP is a modular prosthetic component that connects the socket and the foot components and allows added compression and twisting along the pylon In both sets of prostheses conditions the participants will wear the same foot component provided by the research team For each of the two sets of prostheses with and without SAP the participants will make up to 5 visits to the laboratory ie up to 10 total visits for the entire protocol Each visit will involve data collections under a variety of walking tasks such as walking on various slopes and turning The same data collections will be repeated with the other set of prostheses
It is hypothesized that the temperatures of tissues above the amputation site and in the opposite intact foot are associated with mechanical factors during walking such as shear forces and work ie energy It is also hypothesized that impaired temperature regulation especially in people with diabetes is associated with poor vascular function that inhibits effective blood circulation and oxygen delivery to affected tissues Lastly it is hypothesized that walking with a shock-absorbing prosthetic component can improve comfort and improve temperature regulation of tissues above the amputation site
This project will recruit 40 individuals with a unilateral transtibial below-knee amputation divided into two groups with and without diabetes All individuals will be given two sets of prostheses with and without a shock-absorbing pylon SAP SAP is a modular prosthetic component that connects the socket and the foot components and allows added compression and twisting along the pylon In both sets of prostheses conditions the participants will wear the same foot component provided by the research team For each of the two sets of prostheses with and without SAP the participants will make up to 5 visits to the laboratory ie up to 10 total visits for the entire protocol Each visit will involve data collections under a variety of walking tasks such as walking on various slopes and turning The same data collections will be repeated with the other set of prostheses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None