Diagnostics in the Leg Ulcer Pathway

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.

Completed

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Charing Cross Hospital

London, W6 8RF, United Kingdom

About this study

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.

To determine the current practice in primary care for venous leg ulcer management and availability of services to onward referral.
To determine the current practice for diagnosis and management of suspected venous leg ulcers in vascular scientist departments across the UK
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.
To determine the cost effectiveness of implementing this in both primary and secondary care settings.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

N/A - Questionnaire based study

Other

Questionnaire based study

Primary outcomes

Primary Care Practitioners and the Management of Venous Leg Ulcers.

Time frame: 3 months

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.
Vascular Scientists

Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

Imperial College Healthcare NHS Trust

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2025
First posted: Dec 26, 2023
Registry last updated: Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed