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Diagnostics in the Leg Ulcer Pathway

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
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06181708
Enrollment
135
Registered
2023-12-26
Start date
2023-11-13
Completion date
2025-05-26
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Leg Ulcer

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.

Interventions

OTHERN/A - Questionnaire based study

Questionnaire based study

Sponsors

Imperial College London
Lead SponsorOTHER
Imperial College Healthcare NHS Trust
CollaboratorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Primary Care Practitioners and the Management of Venous Leg Ulcers.3 monthsWhat 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.
Vascular Scientists3 monthsTo 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

Countries

United Kingdom

Contacts

PRINCIPAL_INVESTIGATORAlun Davies

Imperial College London

Participant flow

Participants by arm

ArmCount
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
92
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
43
Total135

Baseline characteristics

CharacteristicTotal
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
0 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

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.

Time frame: 3 months

Population: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Primary Care PractitionersPrimary Care Practitioners and the Management of Venous Leg Ulcers.What % of respondents have access to onward specialist referral for venous leg ulcer management?50 Participants
Primary Care PractitionersPrimary Care Practitioners and the Management of Venous Leg Ulcers.What percentage of primary care practitioners have access to refer for venous duplex imaging?34 Participants
Primary Care PractitionersPrimary Care Practitioners and the Management of Venous Leg Ulcers.What % of PCP felt there needs to be clearer guidelines on management of patients with VLUs.45 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

Time frame: 3 months

Population: There were 43 responses to the Delphi.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Primary Care PractitionersVascular ScientistsWhat % of respondents felt that specialist leg ulcer clinics should be run?33 Participants
Primary Care PractitionersVascular ScientistsWhat % of respondents felt there needed to be clearer diagnostic guidelines?29 Participants
Primary Care PractitionersVascular ScientistsWhat % felt patients should be able to access an ABPI as part of this clinic?32 Participants
Primary Care PractitionersVascular ScientistsWhat % felt patients should be able to access a venous duplex scan as part of this clinic?24 Participants
Primary Care PractitionersVascular ScientistsWhat % felt leg ulcer clinics should be held in secondary care?22 Participants
Primary Care PractitionersVascular ScientistsWhat % felt compression bandaging should be removed before a venous insufficiency scan?34 Participants

Source: ClinicalTrials.gov · Data processed: Apr 15, 2026