Other Clinical Trial - Diagnostics in the Leg Ulcer Pathway

Status Recruiting

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06181708
Study type	Observational
Source	Imperial College London
Contact	Emma Flint
Phone	02033117322
Email	e.flint1@nhs.net
Status	Recruiting
Phase
Start date	November 13, 2023
Completion date	June 2025

View Details

See also
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Not yet recruiting	`NCT03543007` - Evaluating the Safety and Efficacy of GrafixPL™PRIME for the Treatment of Chronic Venous Leg Ulcers	N/A
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Not yet recruiting	`NCT04613687` - Efficacy and Safety of a New Compression System URGO BD001 in the Treatment of VLU (FREEDOM)	N/A
Recruiting	`NCT05549609` - A Study of XSTEM-VLU in Patients With Difficult-to-heal Venous Leg Ulcers	Phase 1/Phase 2
Recruiting	`NCT05409976` - The GORE® VIAFORT Vascular Stent IVC Study	N/A
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.