Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06181708
Status:
RECRUITING
Last Update Posted:
2024-02-14
First Post:
2023-11-10
Brief Title:
Diagnostics in the Leg Ulcer Pathway
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 roleposition 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None