Actively Recruiting

Age: 18Years +
All Genders
ID06798766

Reducing Health Inequities Through Improved Guidance and Assessment on the Early Identification of Skin Changes Associated With Chronic Venous Insufficiency in People With Dark Skin Tones

Led by King's College London · Updated on 2025-09-16

51

Participants Needed

2

Research Sites

12 weeks

Total Duration

On this page

Sponsors

K

King's College London

Lead Sponsor

G

Guy's and St Thomas' NHS Foundation Trust

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to improve the assessment of chronic venous insufficiency (CVI) specifically in people with dark skin tones. It focuses on defining better criteria for identifying skin changes linked to CVI and understanding patient experiences. The study is designed to inform future nurse-led interventions and clinical practices to reduce health inequities for this population. The study has two parts. The first involves semi-structured interviews with people with dark skin tones who have CVI, exploring their patient journeys and how they recognized skin changes to guide improved assessment techniques. The second part involves physical assessments, skin photography, and clinical evaluations of 15 patients with dark skin tones and known venous disease, including comparisons of standard and enhanced photography methods to better detect skin changes. Participants will be involved through interviews and clinical assessments, including self-reporting skin tone, ethnicity, age, and gender. They will undergo physical examination, answer questions about their symptoms, and participate in photography sessions. Researchers will collect data on clinical scores, patient and clinician experiences, and photograph skin changes. The study includes follow-up interviews shortly after assessments to gather feedback and monitor any adverse events.

CONDITIONS

Brief Title

Reducing Skin Tone Inequities in Chronic Venous Insufficiency

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • People with chronic venous insufficiency or their close family member
  • Person with chronic venous insufficiency has a dark skin tone from Ho and Robinson skin tone range 2b to 6b
  • Ability to give informed consent
  • For physical assessment part, able to travel to hospital and have duplex scan results
Not Eligible

You will not qualify if you...

  • Person with chronic venous insufficiency has a light skin tone from Ho and Robinson skin tone range 1a to 2a
  • People unable to speak and understand English
  • People unable to give informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Mapping Patient Journeys and Experiences

Duration - 1 visit

Participants take part in a semi-structured interview exploring their experiences and journey living with chronic venous insufficiency, including self-reporting skin tone and demographics.

1 interview visit (approximately 1 hour, in-person or remote)

Skin Assessment and Medical Photography

Duration - 1 visit

Participants undergo physical assessment of their lower legs using inspection and palpation, complete symptom questionnaires, and have wound photography using standard and enhanced techniques. They also provide feedback on their experience of these assessments.

1 clinical assessment visit (in-person)

Follow-up Feedback

Duration - Less than 72 hours after assessment

Participants provide feedback on their experience of the skin assessments within 72 hours after the clinical assessment visit.

1 follow-up feedback contact (remote or in-person)

Trial Site Locations

Total: 2 locations

1

Guy's and St Thomas' NHS Foundation Trust

London, London, United Kingdom

Not Yet Recruiting

2

King's College London

London, United Kingdom

Actively Recruiting

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Research Team

V

Victoria J Clemett, PhD, BNurs

S

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

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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