Clinical trial NCT06258343: Extremity Thermographic Values in Individuals With Transtibial Amputation
Official title: Examination of Intact and Amputated Extremity Thermographic Values in Individuals With Transtibial Amputation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Amputees
Amputation
Amputation Stump
Amputation of Knee
Vascularisation
Lead sponsor: Baskent University
Sponsor class: OTHER
Collaborators: name: Gulhane School of Medicine
name: Ankara Yildirim Beyazıt University
First posted: 2024-02-14
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals with unilateral transitibial amputation

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.

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.

Primary outcomes:
measure: Skin Temperature
timeFrame: 30 minutes
Secondary outcomes:
measure: Knee Pain
timeFrame: 10 minutes
measure: Phantom Sensation and Phantom Pain
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Senay Cerezci Duygu
state: Keçiören
Study officials:
References: