Venous Leg UlcerNCT06181708

Diagnostics in the Leg Ulcer Pathway

An observational study of Venous Leg Ulcer, run by Imperial College London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Venous Leg Ulcer
What is being tested?: N/A - Questionnaire based study
How many people: 135 participants
Where: 1 siteUnited Kingdom
Study dates: 13 Nov 2023to 26 May 2025
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Study population: Primary care practitioners working in the UK and Vascular Scientists working in a secondary care hospital in the UK.

Who may be able to join

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.

Who cannot join

Participants not meeting the inclusion criteria.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Charing Cross Hospital
London, W6 8RF

Other trials in United Kingdom

About this study

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

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.

Read the 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.

To determine the current practice in primary care for venous leg ulcer management and availability of services to onward referral.
To determine the current practice for diagnosis and management of suspected venous leg ulcers in vascular scientist departments across the UK
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.
To determine the cost effectiveness of implementing this in both primary and secondary care settings.

Conditions: Venous Leg Ulcer
Being tested: N/A - Questionnaire based study
Medical subject headings: Varicose Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

N/A - Questionnaire based studyOther
Questionnaire based study

Study groups in NCT06181708
Study group	Role	What they receive
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. Receives: Other: N/A - Questionnaire based study
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 Receives: Other: N/A - Questionnaire based study

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Nov 202326 May 2025

First posted26 Dec 2023
Study start13 Nov 2023
Primary completion26 Feb 2024
Study completion26 May 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Venous Leg UlcerStudies of the same condition, open and under way.
More trials run by Imperial College LondonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 135 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06181708
Sponsor's protocol ID: 23CX8458
Status last verified: Mar 2026
First submitted: 10 Nov 2023
Last updated: 14 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
Venous Thromboses, Venous Disease
Not yet recruiting
Subcutaneous Dexpanthenol Administration and Wound Epithelialization
Chronic Wounds, Diabetic Foot Ulcer
Not yet recruitingPhase 2
Controlled Study, Performed to Evaluate the Safety and Efficacy of EscharEx and Its Placebo (Gel Vehicle) Compared to Non-surgical Standard of Care in Participants With Venous Leg Ulcers (VLU)
Venus Leg Ulcers
RecruitingPhase 3
A Double Blind Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of VLU (VALUE)
Venous Leg Ulcer (VLU)
Not yet recruitingPhase 1/2
Evaluating Autologous Platelet-Rich Fibrin Plasma for Chronic Lower Extremity Ulcers
Lower Extremity, Chronic Ulcers

All Venous Leg Ulcer trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT06181708
Acronym / sponsor ID: 23CX8458
Conditions: Venous Leg Ulcer
Study type: Observational
Recruitment status: Completed
Enrolment: 135 participants (actual)
Lead sponsor: Imperial College LondonUniversity, hospital or other
Collaborators: Imperial College Healthcare NHS Trust
Study start: 13 Nov 2023 (actual)
Primary completion: 26 Feb 2024 (actual)
Study completion: 26 May 2025 (actual)
First posted: 26 Dec 2023 (actual)
Results: Posted 29 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

To determine the current practice in primary care for venous leg ulcer management and availability of services to onward referral.
To determine the current practice for diagnosis and management of suspected venous leg ulcers in vascular scientist departments across the UK
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.
To determine the cost effectiveness of implementing this in both primary and secondary care settings.

Study design

Observational model: Other
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Primary care practitioners	–	Other: N/A - Questionnaire based studyA 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	–	Other: N/A - Questionnaire based studyA 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

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult
Study population: Primary care practitioners working in the UK and Vascular Scientists working in a secondary care hospital in the UK.

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (1 listed)

Participants not meeting the inclusion criteria.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
N/A - Questionnaire based studyQuestionnaire based study	Other	Primary care practitioners, Vascular Scientists

Primary outcome

Primary Care Practitioners and the Management of Venous Leg Ulcers.
Time frame: 3 months
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.
Vascular Scientists
Time frame: 3 months
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

Results and safety

Results posted to the registry on 29 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Primary Care Practitioners	92	92
Vascular Scientists	43	36

Primary outcome: Primary Care Practitioners and the Management of Venous Leg Ulcers.

Time frame: 3 months. Count of participants. Unit: Participants

Measure	Primary Care Practitioners n = 92
What % of respondents have access to onward specialist referral for venous leg ulcer management?	50
What percentage of primary care practitioners have access to refer for venous duplex imaging?	34
What % of PCP felt there needs to be clearer guidelines on management of patients with VLUs.	45

Population analysed: 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.

Primary outcome: Vascular Scientists

Time frame: 3 months. Count of participants. Unit: Participants

Measure	Vascular Scientists n = 43
What % of respondents felt there needed to be clearer diagnostic guidelines?	29
What % of respondents felt that specialist leg ulcer clinics should be run?	33
What % felt patients should be able to access an ABPI as part of this clinic?	32
What % felt patients should be able to access a venous duplex scan as part of this clinic?	24
What % felt leg ulcer clinics should be held in secondary care?	22
What % felt compression bandaging should be removed before a venous insufficiency scan?	34

Population analysed: There were 43 responses to the Delphi.

Adverse events

Time frame: N/A. Adverse Events were not monitored/assessed. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Primary Care Practitioners	0 of 0	0 of 0	0
Vascular Scientists	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Venous Leg Ulcer

Recruiting
The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
Venous Thromboses, Venous Disease
Not yet recruiting
Subcutaneous Dexpanthenol Administration and Wound Epithelialization
Chronic Wounds, Diabetic Foot Ulcer
Not yet recruitingPhase 2
Controlled Study, Performed to Evaluate the Safety and Efficacy of EscharEx and Its Placebo (Gel Vehicle) Compared to Non-surgical Standard of Care in Participants With Venous Leg Ulcers (VLU)
Venus Leg Ulcers
RecruitingPhase 3
A Double Blind Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of VLU (VALUE)
Venous Leg Ulcer (VLU)
Not yet recruitingPhase 1/2
Evaluating Autologous Platelet-Rich Fibrin Plasma for Chronic Lower Extremity Ulcers
Lower Extremity, Chronic Ulcers

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alun Davies principal investigator

Imperial College London

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Venous Leg Ulcer, run by Imperial College London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Care Practitioners and the Management of Venous Leg Ulcers. (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06181708.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.