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New study aims to fix racial bias in leg vein disease diagnosis

NCT ID NCT06798766

Knowledge-focused Sponsor: King's College London Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study from King's College London focuses on how to better identify early skin changes from chronic venous insufficiency (CVI) in people with dark skin tones. Researchers will interview patients about their experiences and test new assessment techniques, like using touch and special photography. The goal is to create fairer, more accurate guidelines so that everyone, regardless of skin color, gets the same chance at early diagnosis and care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to better clinical guidelines and assessment tools for diagnosing chronic venous insufficiency in people with dark skin tones, reducing misdiagnosis and health disparities.
What could go wrong
This is a small, early-stage observational study (51 participants) focused on understanding and documenting skin changes. It does not test a treatment, so it will not directly improve health outcomes on its own.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 51 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Apr 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Work-package 1 - Mapping patient journeys and patient experiences Source of participants. People with with chronic venous insufficiency, or their close family member, will be recruited from any of the following : * through charity organisations such as the "Lyndsey Leg Club Foundation". Publicity for recruitment will be available by adverts circulated through their members lists, on social media or as in person posters at events. * people who have previously expressed interest in being involved in research on leg ulcers/ venous insufficiency who have a dark skin tone. * Clinical settings (community or acute setting). Work package 2 - Informing skin assessment technique and medical photography Source of participants. Participants will be recruited from clinical settings within our trust partner organization. This NHS Foundation Trust is the hub of the southeast Thames vascular network, based in London, UK.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

chronic venous insufficiency cortical blindness ulcer of lower limbs Varicose Ulcer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic venous disease of lower limbs Chronic venous insufficiency C2 or higher Chronic venous insufficiency, cvi Venous leg ulcer (VLU)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Guy's and St Thomas' NHS Foundation Trust

    NOT_YET_RECRUITING

    London, London, United Kingdom

  • King's College London

    RECRUITING

    London, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.