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| Name | Class |
|---|---|
| Imperial College Healthcare NHS Trust | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N/A - Questionnaire based study | Other | Questionnaire based study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Care Practitioners and the Management of Venous Leg Ulcers. | What percentage of respondents have access to onward specialist referral for venous leg ulcer management? What percentage of primary care practitioners have access to refer for venous duplex imaging? What percentage of primary care practitioners felt there needs to be clearer guidelines on the management of patients with venous leg ulcers. | 3 months |
| Vascular Scientists | To determine a consensus on the diagnostic management of suspected venous leg ulcers in vascular scientist departments across the UK. What % of respondents felt there needed to be clearer guidelines on how to best manage these patients diagnostically? What % of respondents felt that specialist leg ulcer clinics should be run? What % felt patients should be able to access an ABPI as part of this clinic? What % felt patients should be able to access a venous duplex scan as part of this clinic? What % felt leg ulcer clinics should be held in secondary | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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Primary care practitioners working in the UK and Vascular Scientists working in a secondary care hospital in the UK.
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| Name | Affiliation | Role |
|---|---|---|
| Alun Davies | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charing Cross Hospital | London | W6 8RF | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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: Questionnaire based study |
| FG001 | 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: Questionnaire based study |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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: Questionnaire based study |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age of participants not collected for this study. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Primary Care Practitioners and the Management of Venous Leg Ulcers. | What percentage of respondents have access to onward specialist referral for venous leg ulcer management? What percentage of primary care practitioners have access to refer for venous duplex imaging? What percentage of primary care practitioners felt there needs to be clearer guidelines on the management of patients with venous leg ulcers. | The overall response rate was 92, but it was not compulsory to answer every question in the questionnaire, so some questions had different response rates. | Posted | Count of Participants | Participants | 3 months |
|
N/A. Adverse Events were not monitored/assessed
Adverse Events were not monitored/assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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: Questionnaire based study and therefore adverse Events were not monitored/assessed. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emma Flint | Imperial College Healthcare NHS Trust | 02033117322 | e.flint1@nhs.net |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 18, 2025 | Feb 18, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
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| 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: Questionnaire based study |
| BG002 | Total | Total of all reporting groups |
Age of participant not collected for this study.
| Number |
| years |
|
| Sex: Female, Male | Gender of participants not collected for this study. | Gender of participants not collected for this study. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| Primary | Vascular Scientists | To determine a consensus on the diagnostic management of suspected venous leg ulcers in vascular scientist departments across the UK. What % of respondents felt there needed to be clearer guidelines on how to best manage these patients diagnostically? What % of respondents felt that specialist leg ulcer clinics should be run? What % felt patients should be able to access an ABPI as part of this clinic? What % felt patients should be able to access a venous duplex scan as part of this clinic? What % felt leg ulcer clinics should be held in secondary | There were 43 responses to the Delphi. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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: Questionnaire based study and therefore adverse Events were not monitored/assessed. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D012883 |
| Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
|
| What % felt patients should be able to access an ABPI as part of this clinic? |
|
|
| What % felt patients should be able to access a venous duplex scan as part of this clinic? |
|
|
| What % felt leg ulcer clinics should be held in secondary care? |
|
|
| What % felt compression bandaging should be removed before a venous insufficiency scan? |
|
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