Diagnostics in the Leg Ulcer Pathway

NCT ID: NCT06181708

Last Updated: 2025-04-29

Study Results

Results available

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

135 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-13

Study Completion Date

2025-09-30

Brief Summary

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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

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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

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Venous Leg Ulcer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

N/A - Questionnaire based study

Intervention Type OTHER

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

N/A - Questionnaire based study

Intervention Type OTHER

Questionnaire based study

Interventions

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N/A - Questionnaire based study

Questionnaire based study

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Imperial College Healthcare NHS Trust

OTHER

Sponsor Role collaborator

Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alun Davies

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

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Charing Cross Hospital

London, , United Kingdom

Site Status

Countries

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United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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23CX8458

Identifier Type: -

Identifier Source: org_study_id

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