Reducing Skin Tone Inequities in Chronic Venous Insufficiency (NCT06798766) | Clinical Trial Compass
RecruitingNot Applicable
Reducing Skin Tone Inequities in Chronic Venous Insufficiency
United Kingdom51 participantsStarted 2025-06-01
Plain-language summary
The aim of this project is to define assessment criteria for chronic venous insufficiency (CVI) in people with dark skin tones. It will inform future interventions and modifications to practice for the assessment of CVI in people with dark skin tones in a nurse led intervention to improve patient assessment.
To achieve this there will be two parts to this study.
1. We will explore patient journeys and patient experiences of people with dark skin tones diagnosed with chronic venous insufficiency. From this we will learn from people with dark skin tones about how they recognised skin changes in their lower legs to further inform clinical assessment guidance and techniques. We will also listen to their patient journey to identify what areas worked well and what could be developed. This will help us plan how care could be improved for similar people.
2. We will record how skin changes look and feel in people with dark skin tones and known venous disease, and photograph this. We will consider whether some additional techniques used in practice to look and feel the skin is useful and whether changing the colour balance and manipulating the photographs is useful to see these skin changes.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Work-package 1 - Mapping patient journeys and patient experiences Participant inclusion criteria
* people with chronic venous insufficiency, or their close family member
* the person with chronic venous insufficiency has a dark skin tone (from Ho and Robinson skin tone range 2b-6b, table 1).
* ability to give informed consent Participant exclusion criteria
* person with chronic venous insufficiency has a light skin tone (from Ho and Robinson skin tone range 1a-2a, table 1).
* people unable to speak and understand English
* people unable to give informed consent.
Work package 2 - Informing skin assessment technique and medical photography Participant inclusion criteria
* people diagnosed with chronic venous insufficiency at NHS trust
* people with a dark skin tones (from Ho and Robinson skin tone range 2b-6b, table 1).
* ability to give informed consent
* either coming back to the hospital for surgery or being able to travel back to the hospital to undergo physical assessment and skin photography prior to any intervention.
* have duplex ultra-sound scan informing clinical diagnosis of venous disease. Participant exclusion criteria
* person with chronic venous insufficiency has a light skin tones (from Ho and Robinson skin tone range 1a-2a, table 1).
* people unable to speak and understand English
* people unable to give informed consent.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Work-package 1 - Patient experience
Timeframe: Baseline
2
Work package 2 - Skin assessment of the lower limb
Timeframe: Baseline
3
Work package 2 - Clinical (C) classification of the CEAP
Timeframe: Baseline
4
Work package 2 - Venous Clinical Severity Score
Timeframe: Baseline
5
Work package 2 - Wound photography under standard and modified conditions