Extremity Thermographic Values in Individuals With Transtibial Amputation

NCT06258343 | Completed

• 1 other identifier: 2022-1274
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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. 1.Do thermal values in the knee region of the amputated extremity and the intact extremity differ in individuals with transtibial amputation?
2. 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?

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Skin Temperature

  In both knees, 3 measurements will be taken at the center of the patella, the tibialis anterior muscle trunk (10 cm distal to the tibial tubercle and 2 cm lateral to the anterior border of the tibia) and distal to the limb. Room temperature will be recorded simultaneously. Measurements will be recorded in Celsius. The study will follow the recently published 15-point TISEM consensus statement on the measurement of human Tsk. Within the scope of the study, temperature measurements will be performed using a Medisana 48620 Infrared Non-Contact Thermometer (MEDISANA, FTN, Hilden, Germany).

  30 minutes

Secondary Outcomes (2)

• Knee Pain

  10 minutes

• Phantom Sensation and Phantom Pain

  20 minutes

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals with unilateral transitibial amputation

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Baskent University: lead
• Gulhane School of Medicine: collaborator
• Ankara Yildirim Beyazıt University: collaborator

Study Sites (1)

Senay Cerezci Duygu

Ankara, Keçiören, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neovascularization, Pathologic

Condition Hierarchy (Ancestors)

Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: January 28, 2024
• First Posted: February 14, 2024
• Study Start: September 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: March 1, 2025
• Last Updated: July 10, 2025

Record last verified: 2024-08

Locations

TU (1)