AmputeesNCT06258343
Extremity Thermographic Values in Individuals With Transtibial Amputation
An observational study of Amputees and Amputation, run by Baskent University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Amputees, Amputation, Amputation Stump
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 1 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with unilateral transitibial amputation
Who may be able to join
- 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.
Who cannot join
- Having bilateral amputation,
- Not being able to walk 10 minutes independently,
- Failure to consent to measurement of knee thermal temperature.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examination of Intact and Amputated Extremity Thermographic Values in Individuals With Transtibial Amputation
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:
- Do thermal values in the knee region of the amputated extremity and the intact extremity differ in individuals with transtibial amputation?
- 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?
Read the 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
- Medical subject headings
- Neovascularization, Pathologic
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 30 minutes
Secondary outcomes (2)
Knee Pain
The presence of pain in both knees, pain intensity and localization of pain will be questioned. To determine the presence of pain sensation in the knee region of the patients, the presence or absence of pain sensation in the knee of the intact and amputated extremity will be questioned. In the presence of pain sensation, the 'Visual Analog Scale' will be used to assess the severity of pain in the intact knee and the amputated knee.
For pain intensity assessment with the Visual Analog Scale, a 10 cm long line is drawn. The starting and ending points of the line are numbered 0 and 10. Individuals are asked to mark the intensity of the pain they feel on the scale, indicating that a value of 0 indicates absence of pain and a value of 10 indicates unbearable severe pain. The area marked by the individuals is then measured with a ruler and recorded as pain intensity.
Measured: 10 minutes
Phantom Sensation and Phantom Pain
The presence of phantom limb sensation will be questioned. If there is phantom limb sensation, individuals will be asked to describe their phantom limb sensation with open-ended questions and to provide information about the position of their limbs (fixed or mobile, in anatomical position or in anatomically impossible position), and whether they feel shortening/shrinking or any other condition in their limbs and the presence of telescope phenomenon will be questioned.
The presence or absence of phantom pain will be questioned. If phantom pain is experienced, individuals will be asked to provide information about the area of pain, the frequency/type of pain and to complete the "Short Form Mc-Gill Pain Scale (SF-MPQ)". The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start1 Sep 2024
- Primary completion1 Jan 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputeesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Collaborators
- Gulhane School of Medicine, Ankara Yildirim Beyazıt University
- Responsible party
- Principal investigator, Senay Cerezci Duygu, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06258343
- Sponsor's protocol ID
- 2022-1274
- Status last verified
- Aug 2024
- First submitted
- 28 Jan 2024
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Intact and Amputated Extremity Thermographic Values in Individuals With Transtibial Amputation
- ClinicalTrials.gov ID
- NCT06258343
- Acronym / sponsor ID
- 2022-1274
- Conditions
- Amputees, Amputation, Amputation Stump, Amputation of Knee, Vascularisation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Collaborators
- Gulhane School of Medicine, Ankara Yildirim Beyazıt University
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Do thermal values in the knee region of the amputated extremity and the intact extremity differ in individuals with transtibial amputation?
- 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.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with unilateral transitibial amputation
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Having bilateral amputation,
- Not being able to walk 10 minutes independently,
- Failure to consent to measurement of knee thermal temperature.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Skin Temperature
Time frame: 30 minutes
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).
2 secondary outcomes
Knee Pain
Time frame: 10 minutes
Phantom Sensation and Phantom Pain
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amputees and Amputation, run by Baskent University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin Temperature (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.