- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07334028
Study to Find Out the Timing for the Optimal Imaging of Varicose Veins Using Infrared Thermography.
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
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mark S Whiteley, MS FRCS(Gen) MBBS
- Phone Number: +44 330 058 1850
- Email: mark@thewhiteleyclinic.co.uk
Study Contact Backup
- Name: Theodore AG Spaliviero-Shaw
- Phone Number: +44 330 058 1850
- Email: mark@thewhiteleyclinic.co.uk
Study Locations
-
-
Surrey
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Guildford, Surrey, United Kingdom, GU2 7RF
- Recruiting
- The Whiteley Clinic
-
Contact:
- Mark S Whiteley, MS FRCS MBBS
- Phone Number: +44 330 058 1850
- Email: mark@thewhiteleyclinic.co.uk
-
Contact:
- Naomi S Sheppard
- Phone Number: +44 330 058 1850
- Email: naomi.sheppard@thewhiteleyclinic.co.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
All patients presenting with varicose veins
Primary or recurrent varicose veins
|
Patients will only have infrared images taken of their legs
|
What is the study measuring?
Primary Outcome Measures
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
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
Sponsor
Investigators
- Principal Investigator: Mark S Whiteley, MS FRCS(Gen) MBBS, The Whiteley Clinic
Publications and helpful links
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
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TWC-IR-TAGSS-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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