NCT06181708

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 135 (actual)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

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.

Conditions

• Venous Leg Ulcer

Interventions

Type	Name	Description
OTHER	N/A - Questionnaire based study	Questionnaire based study

Timeline

• Start date: 2023-11-13
• Primary completion: 2024-02-26
• Completion: 2025-05-26
• First posted: 2023-12-26
• Last updated: 2026-04-14
• Results posted: 2025-04-29

Locations

1 site across 1 country: United Kingdom