Extremity Thermographic Values in Individuals With Transtibial Amputation

NCT ID: NCT06258343

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 21 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-03-01

Brief Summary

The goal of this observational study is to compare thermographic values in the knee region of the healthy extremity and the amputated extremity and learn about the relationship between thermographic value and pain in the knee region of the amputated extremity. The main questions it aims to answer are:

1. Do thermal values in the knee region of the amputated extremity and the intact extremity differ in individuals with transtibial amputation?

2. Is there a relationship between the pain felt in the knee region of the amputated limb and the difference in thermal values between the extremities in individuals with transtibial amputation?

Detailed Description

With amputation, anatomical and vascular changes occur in the distal part of the remaining limb. At this point, for individuals with amputation at the transtibial level, the knee joint in the amputated extremity is of critical importance as it is the most distal joint. While there is evidence that thermal changes observed in the knee region may be related to possible degeneration or pathological processes, there is not enough research on the amputee population. Considering that individuals who have undergone lower extremity amputation are at greater risk than the general population for many health problems and considering the current evidence, we think that the evaluation of skin temperature, which is an indicator of cutaneous circulation, may be an important indicator in taking precautions for degenerative knee diseases. With the planned study, lower extremity temperature profiles and their relationship with knee pain will be evaluated for the first time during the post-amputation period. Thermal infrared non-contact thermometer, which is non-invasive, cheap and easy to apply, will be used for the first time in lower extremity temperature measurements of amputees.

Objectives of the study,

• Thermal analysis results of both extremities will be compared and it will be investigated whether there is a difference between thermal values, which is one of the indicators of cutaneous blood flow;
• By comparing the thermal values, it will be determined whether the thermal values differ in the amputee limb that has undergone major trauma and is exposed to prosthetic material that applies continuous compression,
• The relationship between nociceptive pain and phantom pain felt in the knee region of the amputated limb and the thermal value difference between the extremities will be determined.

Conditions

Amputees; Amputation; Amputation Stump; Amputation of Knee; Vascularisation

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

• Having a unilateral below knee level amputation,
• Using a prosthesis and being able to walk with the prosthesis,
• Not having undergone any surgery related to the knees.

Exclusion Criteria

• Having bilateral amputation,
• Not being able to walk 10 minutes independently,
• Failure to consent to measurement of knee thermal temperature.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gulhane School of Medicine

OTHER

Sponsor Role: collaborator

Ankara Yildirim Beyazıt University

OTHER

Sponsor Role: collaborator

Baskent University

OTHER

Sponsor Role: lead

Responsible Party

Senay Cerezci Duygu

Asst. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Senay Cerezci Duygu

Ankara, Keçiören, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2022-1274

Identifier Type: -

Identifier Source: org_study_id