Diagnostics in the Leg Ulcer Pathway

Venous Leg Ulcer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06181708
• Other study ID #: 23CX8458
• Status: Recruiting
• Start date: November 13, 2023
• Est. completion date: June 2025

Study information

• Verified date: February 2024
• Source: Imperial College London
• Contact: Emma Flint
• Phone: 02033117322
• Email: e.flint1[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: June 2025
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

Intervention

Other:
• N/A - Questionnaire based study
Questionnaire based study

Locations

Country	Name	City	State
United Kingdom	Charing Cross Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	Imperial College Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Care Practitioners	To determine the current practice in primary care for venous leg ulcer management and availability of services to onward referral. In order to achieve this, a one of online electronic questionnaire has been designed on Qualtrics. This will be disseminated to a variety of primary care practitioners across the UK. This is a questionnaire with multiple choice and free text boxes for answers, the answers will be analysed qualitatively.	3 months
Primary	Vascular Scientists	To determine the current practice for diagnosis and management of suspected venous leg ulcers in vascular scientist departments across the UK. In order to achieve this, a Delphi consensus will be conducted amongst vascular scientists across the UK using online electronic questionnaires have been designed on Qualtrics. It is expected that there will be 3 rounds of questionnaires the Delphi consensus. A consensus will have been achieved when a 70% agreement has been reached on answers to questions. We are not using assessments with unique measurements during this study.	6 months