## Protocol Section
### Identification Module
**NCT ID:** NCT06433024

**Brief Title:** Training of a Artificial Intelligence Model to Detect Venous Diseases Using PPG Technology

**Official Title:** A Pilot Study Using AI Algorithms and PPG Technology for the Detection of Venous Diseases

#### Organization Study ID Info
**ID:** TWC-SD-2024-05
#### Organization
**Class:** OTHER
**Full Name:** The Whiteley Clinic
### Status Module
#### Completion Date
**Date:** 2024-09

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-29

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-07

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** The Whiteley Clinic

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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. 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 Module

**Conditions:**

- Venous Disease

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants who have been diagnosed with Chronic Venous Disease (CVD).

**Intervention Names:**

- Diagnostic Test: PPG Diagnostic

**Label:** Individuals with CVD (Treatment Group)

#### Arm Group 2

**Description:** Participants who have not been diagnosed with CVD.

**Intervention Names:**

- Diagnostic Test: PPG Diagnostic

**Label:** Individuals Without CVD (Control Group)

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Individuals Without CVD (Control Group)

- Individuals with CVD (Treatment Group)

**Description:** 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.

**Name:** PPG Diagnostic

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Diagnostic Accuracy of an AI Model for Venous Disease Detection Using PPG Signals

**Time Frame:** June 2024 - September 2024

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

**Healthy Volunteers:** True

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- 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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** people@thewhiteleyclinic.co.uk

**Name:** Sergio Da Silva, PhD

**Phone:** 01483477199

**Role:** CONTACT

**Contact 2:**

**Email:** serah.duro@thewhiteleyclinic.co.uk

**Name:** Serah Duro, MSc

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Guildford

**Country:** United Kingdom

**Facility:** The Whiteley Clinic

**Zip:** GU2 7RF

#### Overall Officials

**Official 1:**

**Affiliation:** The Whiteley Clinic

**Name:** Mark Whiteley

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
