Reducing Skin Tone Inequities in Chronic Venous Insufficiency

NCT06798766 | Recruiting

• 2 other identifiers: EDGE reference 175656IRAS Number 350871
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 2

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. 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. 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.

Conditions

Chronic Venous Insufficiency, CVI; Chronic Venous Insufficiency C2 or Higher; Chronic Venous Disease of Lower Limbs; Venous Leg Ulcer (VLU)

Keywords

health inequities; skin tone inequities; health equality; skin tone equality; skin assessment; physical examination; patient journey; patient experience

Outcome Measures

Primary Outcomes (5)

• Work-package 1 - Patient experience

  No quantitative outcomes will be assessed in the interview study to map patient journey and patient experience.

  Baseline

• Work package 2 - Skin assessment of the lower limb

  the clinical researcher / research nurse will follow guidance on assessing the skin in people with dark skin tones. The current guidance on this includes using touch (palpation) as well as visualising skin changes to feel for any temperature change or tightness, and asking the patient whether they have noticed any changes in appearance of have any symptoms such as pain, itching or sensation changes. Al In addition to the assessments recommended in existing clinical guidelines, there is an indication from our recent qualitative interviews with specialist staff, some clinicians have refined their skills and techniques to assist them to undertake, what they perceive to be, a more accurate assessment on people with dark skin tones. This includes several techniques that have not been reported elsewhere including the use of transillumination and extending the skin to visualize changes. All these assessments will be reported for each patient.

  Baseline

• Work package 2 - Clinical (C) classification of the CEAP

  This assessment will be based on the Clinical (C) classification of the CEAP, which is the most widely used tool for venous disease classification and recommended by international guidelines. These may not be readily observed in patients with dark skin tones, especially by non-specialist clinicians. The clinical researcher / research nurse will base their clinical interpretation of CEAP score based on their assessments of skin changes. Individual observations will be reported alongside the classification assigned. This scale denotes clinical classification of skin changes from C0 (no visible or palpable signs of venous disease) to C6 (an active venous ulcer).

  Baseline

• Work package 2 - Venous Clinical Severity Score

  This is a a widely used tool for rating clinical severity which guidance suggests should be considered in research on venous disease. The clinical researcher / research nurse will base their clinical interpretation of each component of the venous clinical severity score based on their assessments of skin changes and patient assessment. Individual observations will be reported alongside the classifications assigned. This scale scores several components such as pain, varicose veins, venous oedema, pigmentation, inflammation, induration, active ulcers, use of compression. Each question can score between 0 and 3 points, where more points equates to more severe.

  Baseline

• Work package 2 - Wound photography under standard and modified conditions

  These images will provide proof of concept whether skin photography techniques can be modified to improve skin changes associated with venous hypertension and chronic venous disease on people with dark skin tones. This following suggestions in previous research on skin assessment in people with dark skin tones that modifying the photographs is advantageous to assess for erythema associated with pressure damage in the laboratory setting. However, to date no research has considered whether this could be advantageous to assist in the detection of skin changes associated with CVI, or could be undertaken in the clinical setting.

  Baseline

Secondary Outcomes (2)

• Work package 2 - Patient experience

  Follow up (less than 72 hours after data obtained)

• Work package 2 - Clinican experience

  Follow up (less than 24 hours after data obtained)

Study Arms (2)

Work-package 1 - Mapping patient journeys and patient experiences

Participating in semi-structured interview exploring patient experience and patient journey of people with dark skin tones living with chronic venous insufficiency in the U.K. Number of people: 36

Work package 2 - Informing skin assessment technique and medical photography

People with dark skin tones and known chronic venous insufficiency with up to date scan results of their blood flow seen by our trust partner (the hub of the southeast Thames vascular network) by either acute or community services. Number of people: 15

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• King's College London: lead
• Guy's and St Thomas' NHS Foundation Trust: collaborator
• University of Surrey: collaborator

Study Sites (2)

Guy's and St Thomas' NHS Foundation Trust

London, London, United Kingdom

NOT YET RECRUITING

King's College London

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Blindness, Cortical; Varicose Ulcer

Condition Hierarchy (Ancestors)

Blindness; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Victoria J Clemett, PhD, BNurs

  King' College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Victoria J Clemett, PhD, BNurs

CONTACT

+44 20 7836 5454; victoria.clemett@kcl.ac.uk

Sue Woodward, PhD, MSc, PGCEA, RN, FRCN, AKC

CONTACT

+44 20 7848 3469; sue.woodward@kcl.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: January 29, 2025
• Study Start: June 1, 2025
• Primary Completion: January 31, 2026
• Study Completion: April 30, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The study protocol will be available once ethical approval is granted.

Locations

GB (2)