Venous DiseaseNCT06433024
Training of a Artificial Intelligence Model to Detect Venous Diseases Using PPG Technology
An observational study of Venous Disease, run by The Whiteley Clinic at 1 site in United Kingdom.
Trial summary
This clinical research aims to evaluate the effectiveness of using Photoplethysmography (PPG) signals combined with Artificial Intelligence (AI) algorithms, for the precise classification and diagnosis of Venous Diseases of the lower limb. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Venous Disease
- What is being tested?
- PPG Diagnostic
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2024to Sep 2024
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study invites a group of participants who have attended The Whiteley Clinic (hereinafter referred to as TWC). The Participants are split into control (healthy individuals) and treatment (previously diagnosed with Venous disease) groups.
Who may be able to join
- Patients are attending for investigation of suspected venous disease. Patients must be able to walk and mobile normally and have good skin integrity of the lower leg, where the PPG is attached.
- All patients attending TWC are 18 years or older.
Who cannot join
- Subjects with known arterial occlusive disease or physical disability affecting gait or ankle movement will be excluded.
- Patients unable to have a PPG attached to the lower leg (ie: active ulceration) will be excluded.
- Patients unable to give consent. Pregnant female.
Trial locations and contacts
1 site in 1 country.
Serah Duro, MSc contact
About this study
Official title: A Pilot Study Using AI Algorithms and PPG Technology for the Detection of Venous Diseases
This clinical research aims to evaluate the effectiveness of using Photoplethysmography (PPG) signals combined with Artificial Intelligence (AI) algorithms, for the precise classification and diagnosis of Venous Diseases of the lower limb. This study invites a group of participants who currently undergoing investigations for venous disease at The Whiteley Clinic (hereinafter referred to as TWC). The Participants will be classified into control (healthy individuals with no significant venous disease) and chronic venous disease (CVD) (diagnosed with proven venous disease) groups. Prospective participants who express an interest in being included in the study will be given a patient information sheet and will undergo a briefing of the pilot study. If they consent and sign the relevant consent forms, the participants will perform a series of standardized exercises under the supervision of a consultant vascular surgeon. Throughout the exercises, a data acquisition device attached to the ankle records the PPG signals, capturing the changes in blood volume due to the reflected PPG signals from the red blood cells during the movement. Thus, once the data is collected and recorded, this allows for the analysis of the data of the control group and CVD group against each other. During the analysis of the two groups' PPG signals, the objective lies within the capability to detect subtle nuances in the patterns of the PPG signals during the performed movements using AI algorithms. The AI algorithms will distinguish patterns or features indicating the presence or absence of venous disease. This study seeks to contribute valuable insights into enhancing the diagnosis of venous disease using PPG and AI algorithms, paving novel approaches to Venous healthcare.
- Conditions
- Venous Disease
- Being tested
- PPG Diagnostic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPG DiagnosticDiagnostic test
The study investigates venous competence through three distinct exercises using photoplethysmography (PPG) technology to record blood flow in the leg veins of 20 subjects, split into two groups: those with chronic venous disease (CVD) and those without. The null hypothesis is that there will be no significant difference in venous filling times (VFT) and PPG trace variations between subjects with CVD and those without under different physical conditions. The alternative hypothesis suggests that individuals with CVD will show distinct PPG patterns, particularly shorter VFT and varied pressure changes, indicative of venous reflux or obstruction. This hypothesis is chosen based on prior evidence suggesting observable differences in venous function between affected and non-affected individuals.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with CVD (Treatment Group) | Participants who have been diagnosed with Chronic Venous Disease (CVD). Receives: Diagnostic Test: PPG Diagnostic | |
| Individuals Without CVD (Control Group) | Participants who have not been diagnosed with CVD. Receives: Diagnostic Test: PPG Diagnostic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of an AI Model for Venous Disease Detection Using PPG Signals
The primary outcome measure of this study is to evaluate the diagnostic accuracy of an AI model in detecting venous disease through the using PPG signals. This will be quantified by assessing the sensitivity and specificity of the AI model when analysing PPG signals from healthy participants without venous diease, and non-healthy participants with venous disease, without the need for direct intervention of a vascular consultant. These results will help evaluate the AI model in terms of how accurately it can identify Venous disease.
Measured: June 2024 - September 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study startJun 2024 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous DiseaseStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Whiteley Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Whiteley, Principal investigator, The Whiteley Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06433024
- Sponsor's protocol ID
- TWC-SD-2024-05
- Status last verified
- May 2024
- First submitted
- 22 May 2024
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Using AI Algorithms and PPG Technology for the Detection of Venous Diseases
- ClinicalTrials.gov ID
- NCT06433024
- Acronym / sponsor ID
- TWC-SD-2024-05
- Conditions
- Venous Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Whiteley ClinicUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 29 May 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.
This clinical research aims to evaluate the effectiveness of using Photoplethysmography (PPG) signals combined with Artificial Intelligence (AI) algorithms, for the precise classification and diagnosis of Venous Diseases of the lower limb. This study invites a group of participants who currently undergoing investigations for venous disease at The Whiteley Clinic (hereinafter referred to as TWC). The Participants will be classified into control (healthy individuals with no significant venous disease) and chronic venous disease (CVD) (diagnosed with proven venous disease) groups. Prospective participants who express an interest in being included in the study will be given a patient information sheet and will undergo a briefing of the pilot study. If they consent and sign the relevant consent forms, the participants will perform a series of standardized exercises under the supervision of a consultant vascular surgeon. Throughout the exercises, a data acquisition device attached to the ankle records the PPG signals, capturing the changes in blood volume due to the reflected PPG signals from the red blood cells during the movement. Thus, once the data is collected and recorded, this allows for the analysis of the data of the control group and CVD group against each other. During the analysis of the two groups' PPG signals, the objective lies within the capability to detect subtle nuances in the patterns of the PPG signals during the performed movements using AI algorithms. The AI algorithms will distinguish patterns or features indicating the presence or absence of venous disease. This study seeks to contribute valuable insights into enhancing the diagnosis of venous disease using PPG and AI algorithms, paving novel approaches to Venous healthcare.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals with CVD (Treatment Group) | – | Diagnostic Test: PPG DiagnosticParticipants who have been diagnosed with Chronic Venous Disease (CVD). |
| Individuals Without CVD (Control Group) | – | Diagnostic Test: PPG DiagnosticParticipants who have not been diagnosed with CVD. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study invites a group of participants who have attended The Whiteley Clinic (hereinafter referred to as TWC). The Participants are split into control (healthy individuals) and treatment (previously diagnosed with Venous disease) groups.
Key inclusion criteria (2 listed)
- Patients are attending for investigation of suspected venous disease. Patients must be able to walk and mobile normally and have good skin integrity of the lower leg, where the PPG is attached.
- All patients attending TWC are 18 years or older.
Key exclusion criteria (3 listed)
- Subjects with known arterial occlusive disease or physical disability affecting gait or ankle movement will be excluded.
- Patients unable to have a PPG attached to the lower leg (ie: active ulceration) will be excluded.
- Patients unable to give consent. Pregnant female.
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 |
|---|---|---|
| PPG DiagnosticThe study investigates venous competence through three distinct exercises using photoplethysmography (PPG) technology to record blood flow in the leg veins of 20 subjects, split into two groups: those with chronic venous disease (CVD) and those without. The null hypothesis is that there will be no significant difference in venous filling times (VFT) and PPG trace variations between subjects with CVD and those without under different physical conditions. The alternative hypothesis suggests that individuals with CVD will show distinct PPG patterns, particularly shorter VFT and varied pressure changes, indicative of venous reflux or obstruction. This hypothesis is chosen based on prior evidence suggesting observable differences in venous function between affected and non-affected individuals. | Diagnostic test | Individuals Without CVD (Control Group), Individuals with CVD (Treatment Group) |
Primary outcome
Diagnostic Accuracy of an AI Model for Venous Disease Detection Using PPG Signals
Time frame: June 2024 - September 2024
The primary outcome measure of this study is to evaluate the diagnostic accuracy of an AI model in detecting venous disease through the using PPG signals. This will be quantified by assessing the sensitivity and specificity of the AI model when analysing PPG signals from healthy participants without venous diease, and non-healthy participants with venous disease, without the need for direct intervention of a vascular consultant. These results will help evaluate the AI model in terms of how accurately it can identify Venous disease.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Individual participant dataSharing planned: No
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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.
Serah Duro, MSc contact
Mark Whiteley 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 Venous Disease, 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 2 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: status not confirmed, as of the sponsor's last update on 31 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sergio Da Silva, PhD (01483477199, people@thewhiteleyclinic.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of an AI Model for Venous Disease Detection Using PPG Signals (time frame: June 2024 - September 2024). 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 31 May 2024.