Study to Find Out the Timing for the Optimal Imaging of Varicose Veins Using Infrared Thermography.

January 5, 2026 updated by: Mark Whiteley, The Whiteley Clinic

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patient attending our vein clinc for assessement of their varicose veins

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Refusing consent.
  • Unable to get on a couch or stand unaided.
  • Unable to stand still for 5 minutes.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
All patients presenting with varicose veins
Primary or recurrent varicose veins
Diagnostic test: Infrared imaging
Patients will only have infrared images taken of their legs

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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.
The patient data collection will be within 20 minutes, and the analysis within 1 month.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Whiteley Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mark S Whiteley, MS FRCS(Gen) MBBS, The Whiteley Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 26, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 26, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 26, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 3, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2026

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 12, 2026

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TWC-IR-TAGSS-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD is not relevant to the outcomes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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