Reducing skin tone inequities in chronic venous insufficiency care
Reducing Health Inequities Through Improved Guidance and Assessment on the Early Identification of Skin Changes Associated With Chronic Venous Insufficiency (CVI) in People With Dark Skin Tones
This project will try ways to recognize and document leg skin changes in people with darker skin tones who have chronic venous insufficiency.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 51 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | King's College London Academic / other |
| Locations | 2 sites (London, London and 1 other locations) |
| Trial ID | NCT06798766 on ClinicalTrials.gov |
What this trial studies
The project has two parts: interviews to map patient journeys and experiences, and clinical photography and skin examinations to record how CVI presents on darker skin. In the first work package researchers will conduct qualitative interviews with people with dark skin tones (Ho & Robinson 2b–6b) and/or their close family to learn how they noticed skin changes and where care could be improved. In the second work package participants with confirmed CVI will undergo standardized skin examination and medical photography to define visual and tactile criteria for diagnosis on darker skin. Findings will inform clinical guidance, training materials, and co-designed interventions to reduce diagnostic delays and inequities in nurse-led assessment pathways.
Who should consider this trial
Good fit: Adults with diagnosed chronic venous insufficiency (or their close family members) who have darker skin tones (Ho & Robinson 2b–6b), can give informed consent, and (for the photography part) can attend the London study sites.
Not a fit: People with lighter skin tones, those unable to consent or speak English, or those unable to travel to the hospital are not eligible and are unlikely to benefit directly from this project.
Why it matters
Potential benefit: If successful, the work could lead to clearer diagnostic signs and better training that reduce delays and inequities in CVI care for people with darker skin.
How similar studies have performed: While prior work has documented skin tone disparities in dermatology and wound care, systematic criteria for recognizing CVI on darker skin are limited, so this approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
London, London and 1 other locations
- Guy's and St Thomas' NHS Foundation Trust — London, London, United Kingdom (Not_yet_recruiting)
- King's College London — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Victoria J Clemett, PhD, BNurs — King' College London
- Study coordinator: Victoria J Clemett, PhD, BNurs
- Email: victoria.clemett@kcl.ac.uk
- Phone: +44 20 7836 5454
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.