NCT06798766 Reducing Skin Tone Inequities in Chronic Venous Insufficiency

Eligibility & Interventions

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 51 participants in total. It began in 2025-06-01 with a primary completion date of 2026-01-31.

Brief 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.

Eligibility Criteria

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.

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