Diagnostics in the Leg Ulcer Pathway

Estimating & Comparing the Performance, Clinical Effectiveness, and Cost-effectiveness of Current Diagnostic Options for Patients That Present to Primary Care With Suspected Venous Ulcers

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.

Study Overview

• Status: Completed
• Conditions: Venous Leg Ulcer
• Intervention / Treatment: Other: N/A - Questionnaire based study

Detailed Description

The main objective of this project is to determine the role/position of diagnostic imaging in the patient journey for a patient with active or healed ulceration.

1. To determine the current practice in primary care for venous leg ulcer management and availability of services to onward referral.
2. To determine the current practice for diagnosis and management of suspected venous leg ulcers in vascular scientist departments across the UK
3. To establish what the minimum diagnostics should be for this cohort of patients including what scans should be performed and can a set criterion be applied to this cohort of patients.
4. To determine the cost effectiveness of implementing this in both primary and secondary care settings.

• Study Type: Observational
• Enrollment (Actual): 135

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, W6 8RF
    • Charing Cross Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Participants not meeting the inclusion criteria.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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; Questionnaire based study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Imperial College London
• Collaborators: Imperial College Healthcare NHS Trust
• Investigators: Principal Investigator: Alun Davies, Imperial College London

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2023
• Primary Completion (Actual): February 26, 2024
• Study Completion (Actual): May 26, 2025

Study Registration Dates

• First Submitted: November 10, 2023
• First Submitted That Met QC Criteria: December 12, 2023
• First Posted (Actual): December 26, 2023

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Leg Ulcer; Skin and Connective Tissue Diseases; Varicose Ulcer
• Other Study ID Numbers: 23CX8458

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No