Clinical trial NCT06181708: Diagnostics in the Leg Ulcer Pathway
Official 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Venous Leg Ulcer
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Imperial College Healthcare NHS Trust
First posted: 2023-12-26
Enrollment: 135
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary Care Practitioners and the Management of Venous Leg Ulcers.
timeFrame: 3 months
measure: Vascular Scientists
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Charing Cross Hospital
Study officials:
affiliation: Imperial College London
name: Alun Davies
role: PRINCIPAL_INVESTIGATOR
References: