Diagnostics in the Leg Ulcer Pathway

NCT06181708 | Completed Results

• 1 other identifier: 23CX8458
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

This project aims to investigate 'The minimum diagnostic requirements for patients presenting to primary care with suspected venous ulcers.' In order to do this, the investigators intend to run a series of questionnaires with primary care services, vascular science services, and perform some cost effectiveness modelling on running diagnostic services in primary care and in secondary care settings. A one off questionnaire, designed in Qualtrics, will be sent out to primary care practitioners via social media and email contacts. This will be aimed at establishing their current role and any guidelines they follow with regards to the diagnosis and management of venous leg ulcers in primary care, and to determine their opinion of what this patient pathway should involve. A Delphi consensus will be carried out amongst vascular scientists across the UK to determine current and streamline future practice in diagnostics for patients with venous leg ulcers. The consensus will be achieved when there is ≥ 70% agreement. Cost effectiveness modelling will be carried out on two different scenarios of managing this cohort of patients, one in primary care and one in secondary care settings. Descriptive statistics will be performed on the results.

Conditions

Venous Leg Ulcer

Outcome Measures

Primary Outcomes (2)

• Primary Care Practitioners and the Management of Venous Leg Ulcers.

  What percentage of respondents have access to onward specialist referral for venous leg ulcer management? What percentage of primary care practitioners have access to refer for venous duplex imaging? What percentage of primary care practitioners felt there needs to be clearer guidelines on the management of patients with venous leg ulcers.

  3 months

• Vascular Scientists

  To determine a consensus on the diagnostic management of suspected venous leg ulcers in vascular scientist departments across the UK. What % of respondents felt there needed to be clearer guidelines on how to best manage these patients diagnostically? What % of respondents felt that specialist leg ulcer clinics should be run? What % felt patients should be able to access an ABPI as part of this clinic? What % felt patients should be able to access a venous duplex scan as part of this clinic? What % felt leg ulcer clinics should be held in secondary

  3 months

Study Arms (2)

Primary care practitioners

A one off questionnaire to be sent to primary care practitioners via qualtrics to determine the current practice in primary care for venous leg ulcer management and availability of services to onward referral.

Other: N/A - Questionnaire based study

Vascular Scientists

A Delphi Consensus questionnaire will be performed via Qualtrics to determine the current practice for diagnosis and management of suspected venous leg ulcers in vascular scientist departments across the UK

Other: N/A - Questionnaire based study

Interventions

N/A - Questionnaire based study OTHER

Questionnaire based study

Primary care practitioners; Vascular Scientists

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care practitioners working in the UK and Vascular Scientists working in a secondary care hospital in the UK.

You may qualify if:

• Primary care practitioners working in the UK will be recruited for the primary care questionnaire.
• Vascular Scientists working in a secondary care hospital in the UK will be recruited for the online delphi consensus.

Sponsors & Collaborators

• Imperial College London: lead
• Imperial College Healthcare NHS Trust: collaborator

Study Sites (1)

Charing Cross Hospital

London, W6 8RF, United Kingdom

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Emma Flint
• Organization: Imperial College Healthcare NHS Trust

e.flint1@nhs.net

02033117322

Study Officials

• Alun Davies

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: December 26, 2023
• Study Start: November 13, 2023
• Primary Completion: February 26, 2024
• Study Completion: May 26, 2025
• Last Updated: April 14, 2026
• Results First Posted: April 29, 2025

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)