Varicose Veins LegNCT07334028
Study to Find Out the Timing for the Optimal Imaging of Varicose Veins Using Infrared Thermography.
An observational study of Varicose Veins Leg, run by The Whiteley Clinic at 1 site in United Kingdom.
Trial summary
The goal of this observational study is to identify the optimal time of Infrared imaging of varicose veins when patients move from a lying to a standing position. The primary purpose is to enable us to improve our imaging of varicose veins in patients presenting with primary or recurrent leg varicose veins. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Veins Leg
- What is being tested?
- Infrared imaging
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Sep 2025to 26 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patient attending our vein clinc for assessement of their varicose veins
Who may be able to join
- Patients undergoing venous duplex ultrasound scan for suspected varicose veins (primary or recurrent).
- Able to stand still for 5 minutes.
- Able to get on to and off of the surgical couch unaided.
- Patient giving consent.
Who cannot join
- Refusing consent.
- Unable to get on a couch or stand unaided.
- Unable to stand still for 5 minutes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
The Whiteley Clinic
Guildford, Surrey, GU2 7RF
Mark S Whiteley, MS FRCS MBBS, +44 330 058 1850, mark@thewhiteleyclinic.co.uk
Naomi S Sheppard, +44 330 058 1850, naomi.sheppard@thewhiteleyclinic.co.uk
About this study
Official title: Observational Study to Ascertain the Optimum Time to Observe the Infra-red Image of Varicose Veins in the Lower Limb When Standing From a Supine Position.
The goal of this observational study is to identify the optimal time of Infrared imaging of varicose veins when patients move from a lying to a standing position.
The primary purpose is to enable us to improve our imaging of varicose veins in patients presenting with primary or recurrent leg varicose veins.
The main questions it aims to answer are:
Outcome measure 1- How long after standing up from lying supine do leg varicose veins show up best on infrared imaging? Outcome measure 2 - Is there any difference in this timing between varicose veins arising from different sources in the leg?
Patients will be asked to stand, and sequential infrared images will be taken every 5 seconds for 3 minutes.
Read the detailed description
Patients who are having a Duplex ultrasound of their lower-limb veins for the assessment of varicose veins (primary or recurrent) and who have consented to participation in the study will be taken from the scanning room to the research room (within 20 meters).
The patient will be asked for their height and weight to enable BMI to be calculated. The patient will then lie down horizontally for 5 minutes on a bed in the research room. At the end of the 5 minutes, an IR image will be taken of the participant's lower limbs to ensure clearance of varicose veins.
The patient will then be asked to stand in front of an IR camera on a mat with marked positions for their feet on the floor in a position ensuring maximum surface area coverage of lower-limb varicose veins by the camera. The patient will stand still for a period of 3 minutes whilst the IR camera (HIKMICRO M10) takes a series of JPEG photos every 5 seconds. The position of the camera will be adjusted so that the top of the image is at the level of the hip, and the bottom of the image at the sole of the foot. Hence, the image size will be maximised to include the whole leg.
The first image will be taken immediately the patient stands and is in position, minimising any lag and aiming to be within 5 seconds of starting to move from the supine position. After 3 minutes, the patient will be able to sit down and then return to the consultation room.
- Conditions
- Varicose Veins Leg
- Being tested
- Infrared imaging
- Keywords
- varicose vein, infrared imaging
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infrared imagingDiagnostic test
Patients will only have infrared images taken of their legs
| Study group | Role | What they receive |
|---|---|---|
| All patients presenting with varicose veins | Primary or recurrent varicose veins Receives: Diagnostic Test: Infrared imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of optimal Infrared imaging of leg varicose veins after standing from lying
Sequential infrared images will show us at what time point the optimal infrared images have been obtained.
Measured: The whole process for the patient will be a maximum of 20 minutes. The analysis of all of the images will be completed within 1 month of the end of the data collection.
Secondary outcomes (1)
Variation of optimal infrared image timing due to the source of venous reflux
Using the infrared images and comparing them with the duplex ultrasound scans that the patient is having as part of their normal medical assessment, we will subdivide the images by the underlying source of the varicose veins and venous reflux. We will assess whether there is a different time to optimal Infrared imaging with different patterns of venous reflux, predominantly great or small saphenous reflux.
Measured: The patient data collection will be within 20 minutes, and the analysis within 1 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start26 Sep 2025
- Primary completion26 Sep 2026 (estimated)
- Study completion26 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Varicose Veins LegStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Whiteley Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Whiteley, The Whiteley Clinic
- Investigators
- Mark S Whiteley, MS FRCS(Gen) MBBS, Principal investigator, The Whiteley Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07334028
- Sponsor's protocol ID
- TWC-IR-TAGSS-001
- Status last verified
- Jan 2026
- First submitted
- 3 Sep 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD is not relevant to the outcomes
Publications
Brian Meneses-Claudio, W. A.-D.-G. (2019). Detection of Suspicions of Varicose Veins in the Legs using Thermal Imaging. International Journal of Advanced Computer Science and Applications(IJACSA). doi:10.14569/IJACSA.2019.0100554
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Ascertain the Optimum Time to Observe the Infra-red Image of Varicose Veins in the Lower Limb When Standing From a Supine Position.
- ClinicalTrials.gov ID
- NCT07334028
- Acronym / sponsor ID
- TWC-IR-TAGSS-001
- Conditions
- Varicose Veins Leg
- Keywords
- varicose vein, infrared imaging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Whiteley ClinicUniversity, hospital or other
- Study start
- 26 Sep 2025 (actual)
- Primary completion
- 26 Sep 2026 (estimated)
- Study completion
- 26 Sep 2026 (estimated)
- First posted
- 12 Jan 2026 (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 identify the optimal time of Infrared imaging of varicose veins when patients move from a lying to a standing position.
The primary purpose is to enable us to improve our imaging of varicose veins in patients presenting with primary or recurrent leg varicose veins.
The main questions it aims to answer are:
Outcome measure 1- How long after standing up from lying supine do leg varicose veins show up best on infrared imaging? Outcome measure 2 - Is there any difference in this timing between varicose veins arising from different sources in the leg?
Patients will be asked to stand, and sequential infrared images will be taken every 5 seconds for 3 minutes.
Detailed description
Patients who are having a Duplex ultrasound of their lower-limb veins for the assessment of varicose veins (primary or recurrent) and who have consented to participation in the study will be taken from the scanning room to the research room (within 20 meters).
The patient will be asked for their height and weight to enable BMI to be calculated. The patient will then lie down horizontally for 5 minutes on a bed in the research room. At the end of the 5 minutes, an IR image will be taken of the participant's lower limbs to ensure clearance of varicose veins.
The patient will then be asked to stand in front of an IR camera on a mat with marked positions for their feet on the floor in a position ensuring maximum surface area coverage of lower-limb varicose veins by the camera. The patient will stand still for a period of 3 minutes whilst the IR camera (HIKMICRO M10) takes a series of JPEG photos every 5 seconds. The position of the camera will be adjusted so that the top of the image is at the level of the hip, and the bottom of the image at the sole of the foot. Hence, the image size will be maximised to include the whole leg.
The first image will be taken immediately the patient stands and is in position, minimising any lag and aiming to be within 5 seconds of starting to move from the supine position. After 3 minutes, the patient will be able to sit down and then return to the consultation room.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients presenting with varicose veins | – | Diagnostic Test: Infrared imagingPrimary or recurrent varicose veins |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patient attending our vein clinc for assessement of their varicose veins
Key inclusion criteria (4 listed)
- Patients undergoing venous duplex ultrasound scan for suspected varicose veins (primary or recurrent).
- Able to stand still for 5 minutes.
- Able to get on to and off of the surgical couch unaided.
- Patient giving consent.
Key exclusion criteria (3 listed)
- Refusing consent.
- Unable to get on a couch or stand unaided.
- Unable to stand still for 5 minutes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infrared imagingPatients will only have infrared images taken of their legs | Diagnostic test | All patients presenting with varicose veins |
Primary outcome
Time of optimal Infrared imaging of leg varicose veins after standing from lying
Time frame: The whole process for the patient will be a maximum of 20 minutes. The analysis of all of the images will be completed within 1 month of the end of the data collection.
Sequential infrared images will show us at what time point the optimal infrared images have been obtained.
1 secondary outcome
Variation of optimal infrared image timing due to the source of venous reflux
Time frame: The patient data collection will be within 20 minutes, and the analysis within 1 month.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- BackgroundBrian Meneses-Claudio, W. A.-D.-G. (2019). Detection of Suspicions of Varicose Veins in the Legs using Thermal Imaging. International Journal of Advanced Computer Science and Applications(IJACSA). doi:10.14569/IJACSA.2019.0100554
- Individual participant dataSharing planned: No. IPD is not relevant to the outcomes
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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.
Mark S Whiteley, MS FRCS(Gen) MBBS principal investigator
The Whiteley Clinic
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 Varicose Veins Leg, run by The Whiteley Clinic at 1 site in United Kingdom.
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 4 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: looking for participants now, as of the sponsor's last update on 12 Jan 2026. 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 United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark S Whiteley, MS FRCS(Gen) MBBS (+44 330 058 1850, mark@thewhiteleyclinic.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of optimal Infrared imaging of leg varicose veins after standing from lying (time frame: The whole process for the patient will be a maximum of 20 minutes. The analysis of all of the images will be completed within 1 month of the end of the data collection.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07334028, which also lists 1 linked publication.
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 12 Jan 2026.