Compression therapies for the treatment of venous leg ulcers

ISRCTN	ISRCTN67321719
DOI	https://doi.org/10.1186/ISRCTN67321719
IRAS number	280987
Secondary identifying numbers	CPMS 46547, IRAS 280987

Submission date: 07/09/2020
Registration date: 14/09/2020
Last edited: 20/01/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Background and study aims
Venous leg ulcers are common, recurring open wounds on the lower leg. Compression is the first line of treatment for venous leg ulcers. A range of compression therapies such as four-layer bandages two-layer hosiery, two-layer bandages and compression wraps are regularly used in the NHS. However, we are unsure whether one compression therapy is more effective at treating venous leg ulcers than the others. Therefore, this study will aim to investigate the clinical and cost-effectiveness of compression therapies for treating venous leg ulcers.

Who can participate?
Adults with a venous leg ulcer

What does the study involve?
Following obtaining consent, eligible participants will be asked to complete a baseline questionnaire asking about their health and ulcer(s) and have a photo taken of their reference ulcer (as determined by the recruiting healthcare professional). Participants will then be randomly allocated to one of three treatment groups:
1. Compression wraps (adjustable hook-and-loop-fastened compression): A compression sleeve around the foot and leg
2. Evidence based compression (Four-layer bandage or two-layer compression hosiery):The participant and their healthcare professional will decide which treatment they receive. This will be either four layers of compression bandages or two layers of compression stockings
3. Two-layer compression bandage: This bandage will comprise of an initial bandage layer with a top compression bandage

Participants will then continue to see their healthcare professional for routine ulcer treatments to be carried out as normal. The healthcare professional will check how the ulcer is healing and record details of any changes to their treatment. Clinical events such as reference leg healing, ulcer recurrence, amputation, admission and discharge or death will also be recorded if and when they occur.

Once the participant’s ulcer has healed, a photograph of the reference ulcer will be taken once a week for 4 weeks. Following the healing of the leg ulcer, a nurse will also contact the participant once a month, by telephone, to check that the ulcer has not returned.

Whichever treatment a participant receives, they will be asked to complete a questionnaire booklet at 1, 3, 6, and 12 months, asking about their health and ulcer(s). These questionnaires will be sent in the post with a prepaid envelope for their return. A £10 voucher will also be sent to participants at 12 months to thank them for their time.

At the end of the study, participants will return to standard NHS care with their treatment nurse or doctor. If their ulcer does not fully heal during the study the participant’s care will continue with the treatment their doctor or nurse feels is best.

What are the possible benefits and risks of participating?
Every effort will be made to improve a participant’s venous leg ulcers; however, we cannot say whether the ulcer will improve more quickly because of participation in the study. The information we get from this study may have a significant impact upon helping people and healthcare professionals make more informed treatment choices in the future.

Side effects for compression wraps, the two-layer bandage, four-layer bandages and the two-layer hosiery are uncommon and are treatments routinely used in the NHS for patients with venous leg ulcers. There are no anticipated increased risks through participation in this study. Being in the study will not harm or disadvantage your care in any way. Throughout the study, participants will continue to see their health care professional for wound treatments to be carried out as normal.

Where is the study run from?
The study is run from York Trials Unit, University of York (UK) and 16 NHS trusts (UK)

When is the study starting and how long is it expected to run for?
From February 2020 to August 2024

Who is funding the study?
The National Institute for Health Research Health Technology Assessment Programme (Project Number: NIHR128625) (UK)

Who is the main contact?
1. Dr Catherine Arundel (public and scientific contact)
Catherine.arundel@york.ac.uk

Study website

Contact information

Dr Catherine Arundel
Public, Scientific

York Trials Unit
Department of Health Sciences - Faculty of Science
ARRC Building
University of York
York
YO10 5DD
United Kingdom

Phone	+44 (0)1904 321 116
Email	Catherine.arundel@york.ac.uk

Prof Jo Dumville
Scientific

The University of Manchester
Room 5.318
Jean McFarlane Building
Oxford Road
Manchester
M13 9PL
United Kingdom

ORCID ID	0000-0002-6546-3685
Phone	+44 (0)161 306 7830
Email	Jo.dumville@manchester.ac.uk

Study information

Study design	Multi-centre three-arm parallel-group pragmatic randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	A randomised controlled trial of compression therapies for the treatment of venous leg ulcers (VenUS 6)
Study acronym	VenUS 6
Study hypothesis	1. To compare compression wraps with evidence-based compression in terms of the time to healing of venous leg ulcers; 2. To determine whether two-layer bandages are non-inferior to evidence-based compression for time to healing of venous leg ulcers; 3. To determine which is the most cost-effective, full compression treatment for venous leg ulcers
Ethics approval(s)	Approved 15/09/2020, West of Scotland REC 4 (Ward 11, Dykebar Hospital, Grahamston Road, Paisley, PA2 7DE, United Kingdom; +44 (0)141 314 0213; WoSREC4@ggc.scot.nhs.uk), ref: 20/WS/0121
Condition	Venous leg ulcers
Intervention	Current interventions as of 09/02/2024: The study has a 45-month recruitment period in total (comprising and initial 32 month planned recruitment period plus 13 month extension) including an initial 6 month internal pilot. Follow-up will be variable with participants followed for minimum of 4 months and a maximum of 12 months. Prior to study involvement the clinical care team will screen clinical caseloads at trial sites will assess participants against the eligibility criteria. Patients who may be eligible to participate in the study will be approached by a member of the research team and provided with a patient information sheet and asked to indicate if they would be interested in participating. Patients will be given sufficient time to consider this information. Once eligibility has been confirmed, patients must take part in the consent process. During the consent process, the person obtaining consent will inform the participant of all aspects of the trial (e.g. trial procedures, risks/benefits) in order to allow the participant to make an informed decision about their participation. No protocol specific procedures are performed until the participant has signed and dated an Ethics Committee approved informed consent form. Once informed consent has been obtained, baseline data will be collected and participants then randomised. At baseline participant contact details, GP contact details, diabetes status, weight, height and general mobility and ankle mobility will be determined. Ulcer history and assessment such as duration and area of the reference ulcer, number of previous ulcer episodes, ankle–brachial pressure index and ankle circumference. A photo of the reference ulcer (where a participant has multiple ulcers the reference ulcer will be defined as that with the largest surface area) will be taken in order to monitor healing. Following collection of baseline data, the research team will contact the UKCRC-accredited University of York Trials Unit (YTU) via the internet to access a secure randomisation service, which will ensure complete allocation concealment. The randomisation service will record information and check eligibility to avoid inappropriate entry of patients into the trial. Randomisation will be stratified by ulcer duration (<6 months and > 6 months) and ulcer area (< 5cm2 and > 5cm2) using permuted blocks; these variables are known predictors of healing. Participants will be randomly allocated 1:1:1 to either: 1. Arm 1: compression wraps 2. Arm 2: evidence-based compression treatment (choice between four-layer bandage or two layer compression hosiery) 3. Arm 3: two-layer bandage Randomisation will be stratified by ulcer duration (<6 months and >6 months) and ulcer area (<5m2 and >5cm2) using permuted blocks Once randomised, participants will begin their trial treatment as soon as it is available in line with what would happen in routine practice. Participants will continue to receive standard care, including wound dressing changes, as per routine clinical practice. Study data on treatment use and clinical outcomes will be collected weekly during this period by the treatment team. This will include: 1. Healing of the reference ulcer. Treating nurses will be asked to report the date when they consider the reference ulcer and the reference leg has healed. Additionally, data on the reference ulcer will be collected throughout the study in the form of digital images. A digital image will be taken at baseline and again when the treating nurse records the reference ulcer as healed. After this point images will be taken once a week over the next 4 weeks. These images will be assessed by two blinded clinical experts to confirm the date of healing, with disagreements being resolved through discussion and the involvement of a third reviewer if required. 2. Treatments-received (including changes to trial treatment). treatments received will be logged every wound-related nurse visit to the participant, using a case report form, until either the participant’s reference leg (the leg with the reference ulcer on) is ulcer-free and no more nurse visits are required to treat this leg or until the participant exits the trial. The date of visit, the type of compression being received, and the type of primary contact dressing being used will be recorded. These resource use data will be used in economic analyses. If a participant changes from their allocated compression treatment, the date of this change, what they changed to, and the reason for this change; including whether the change from trial treatment was requested by the patient or based on a clinical decision, will b recorded. 3. Healing of the reference leg. Although the clinical analysis defined the primary outcome based on healing of the reference ulcer, the clinically relevant outcome is healing of all ulcers (ulcer free patient). It will be assumed that the reference leg is independent of the non-reference leg (even if this has ulcers), and that healing of the reference leg is the main outcome for evaluation in the economic analysis. 4. Recurrence. Following healing of the reference leg, monthly telephone assessment for ulcer recurrence will take place until the participant exits the trial. The maximum period for trial follow-up will be 12 months following randomisation, although due to variable follow-up some participants will be followed for less time (minimum 4 months). 5. Health-related quality of life assessed using the VEnous INsufficiency Epidemiological and Economic Study - Quality of Life (VEINES-QOL) and the EuroQol 5-dimension 5-level quality of life questionnaire (EQ-5D-5L) at baseline, and at 1, 3, 6, and 12 months follow up (sent and returned via post) 6. Ulcer-related pain will be measured using the Visual Analogue Pain Scale (VAS) at baseline, and at 1, 3, 6, and 12 months follow up (sent and returned via post) 7. Resource use will be determined through a set of questions recording the ulcer-related care from the NHS within the past 3 months at 3, 6 and 12 months (sent and returned via post) 8. Participant adherence and ease of treatment use will be determined through a set of questions assessing views on the compression treatments, volume of treatment use and reasons for reduced dose at 1, 3, 6 and 12 months (sent and returned via post) After the final assessment, participants will return to usual NHS care. Three studies within a trial (SWATs) are planned to assess the effectiveness for methods to improve recruitment and retention: 1. Recruitment SWAT: Evaluation of the effects of presentation of the study design to participants on recruitment rate. Participants will be randomised to receive an infographic (visual document explaining the study) plus the standard patient information sheet (PIS) or just the PIS. 2. Retention SWAT: A 2 by 2 factorial design to simultaneously evaluate the effect of two retention strategies: a participant newsletter and a thank you card sent in advance of follow up questionnaires. Participants will be randomised to receive either: a newsletter and thank you card; a newsletter only; a thank you card only; or neither the newsletter nor the thank you card. These will be sent at Month 4 and Month 9 following randomisation to the VenUS 6 trial. 3. Retention SWAT 2: The researchers will evaluate the effect of including a pen on retention rates. Participants will be randomised to receive 1) a pen; 2) no pen. These will be sent at Month 3 following randomisation to the VenUS 6 trial. Process Evaluation: Understanding participant use of compression treatments To fully understand the findings of the trial the researchers are conducting interviews to gather views and experiences on compression therapies to treat venous leg ulcers, particularly compression wraps. They will conduct semi-structured interviews of approximately 20 participants randomised to different compression treatments. The interviews will use topic guides developed from reviews of the literature on quality of life of people living with venous leg ulcers and consultations with our PPI representatives. The topic guide will explore compression adherence, ease of application, reasons for treatment change, and experiences of wearing different compression treatments. It will be iterative to allow any new themes that arise during interviews to be explored with subsequent participants. Interviews will last around an hour and will take place over telephone or preferred contact method of the participant. The researchers will also conduct up to 10 interviews with nursing staff who deliver compression treatments, as part of VenUS 6, to gather their views and experiences on treatment delivery of compression, especially compression wraps. Previous interventions as of 27/08/2021 to 09/02/2024: The study has a 32-month recruitment period, including an initial 6 month internal pilot. Follow-up will be variable with participants followed for minimum of 4 months and a maximum of 12 months. Prior to study involvement the clinical care team will screen clinical caseloads at trial sites will assess participants against the eligibility criteria. Patients who may be eligible to participate in the study will be approached by a member of the research team and provided with a patient information sheet and asked to indicate if they would be interested in participating. Patients will be given sufficient time to consider this information. Once eligibility has been confirmed, patients must take part in the consent process. During the consent process, the person obtaining consent will inform the participant of all aspects of the trial (e.g. trial procedures, risks/benefits) in order to allow the participant to make an informed decision about their participation. No protocol specific procedures are performed until the participant has signed and dated an Ethics Committee approved informed consent form. Once informed consent has been obtained, baseline data will be collected and participants then randomised. At baseline participant contact details, GP contact details, diabetes status, weight, height and general mobility and ankle mobility will be determined. Ulcer history and assessment such as duration and area of the reference ulcer, number of previous ulcer episodes, ankle–brachial pressure index and ankle circumference. A photo of the reference ulcer (where a participant has multiple ulcers the reference ulcer will be defined as that with the largest surface area) will be taken in order to monitor healing. Following collection of baseline data, the research team will contact the UKCRC-accredited University of York Trials Unit (YTU) via the internet to access a secure randomisation service, which will ensure complete allocation concealment. The randomisation service will record information and check eligibility to avoid inappropriate entry of patients into the trial. Randomisation will be stratified by ulcer duration (<6 months and > 6 months) and ulcer area (< 5cm2 and > 5cm2) using permuted blocks; these variables are known predictors of healing. Participants will be randomly allocated 1:1:1 to either: 1. Arm 1: compression wraps 2. Arm 2: evidence based compression treatment (choice between four layer bandage or two layer compression hosiery) 3. Arm 3: two layer bandage Randomisation will be stratified by ulcer duration (<6 months and >6 months) and ulcer area (<5m2 and >5cm2) using permuted blocks Once randomised, participants will begin their trial treatment as soon as it is available in line with what would happen in routine practice. Participants will continue to receive standard care, including wound dressing changes, as per routine clinical practice. Study data on treatment use and clinical outcomes will be collected weekly during this period by the treatment team. This will include: 1. Healing of the reference ulcer. Treating nurses will be asked to report the date when they consider the reference ulcer and the reference leg has healed. Additionally, data on the reference ulcer will be collected throughout the study in the form of digital images. A digital image will be taken at baseline and again when the treating nurse records the reference ulcer as healed. After this point images will be taken once a week over the next 4 weeks. These images will be assessed by two blinded clinical experts to confirm the date of healing, with disagreements being resolved through discussion and the involvement of a third reviewer if required. 2. Treatments-received (including changes to trial treatment). treatments received will be logged every wound-related nurse visit to the participant, using a case report form, until either the participant’s reference leg (the leg with the reference ulcer on) is ulcer-free and no more nurse visits are required to treat this leg or until the participant exits the trial. The date of visit, the type of compression being received, and the type of primary contact dressing being used will be recorded. These resource use data will be used in economic analyses. If a participant changes from their allocated compression treatment, the date of this change, what they changed to, and the reason for this change; including whether the change from trial treatment was requested by the patient or based on a clinical decision, will b recorded. 3. Healing of the reference leg. Although the clinical analysis defined the primary outcome based on healing of the reference ulcer, the clinically relevant outcome is healing of all ulcers (ulcer free patient). It will be assumed that the reference leg is independent of the non-reference leg (even if this has ulcers), and that healing of the reference leg is the main outcome for evaluation in the economic analysis. 4. Recurrence. Following healing of the reference leg, monthly telephone assessment for ulcer recurrence will take place until the participant exits the trial. The maximum period for trial follow-up will be 12 months following randomisation, although due to variable follow-up some participants will be followed for less time (minimum 4 months). 5. Health related quality of life assessed using the VEnous INsufficiency Epidemiological and Economic Study - Quality of Life (VEINES-QOL) and the EuroQol 5-dimension 5-level quality of life questionnaire (EQ-5D-5L) at baseline, and at 1, 3, 6, and 12 months follow up (sent and returned via post) 6. Ulcer-related pain will be measured using the Visual Analogue Pain Scale (VAS) at baseline, and at 1, 3, 6, and 12 months follow up (sent and returned via post) 7. Resource use will be determined through a set of questions recording the ulcer-related care from the NHS within the past 3 months at 3, 6 and 12 months (sent and returned via post) 8. Participant adherence and ease of treatment use will be determined through a set of questions assessing views on the compression treatments, volume of treatment use and reasons for reduced dose at 1, 3, 6 and 12 months (sent and returned via post) After the final assessment, participants will return to usual NHS care. Three studies within a trial (SWATs) are planned to assess the effectiveness for methods to improve recruitment and retention: 1. Recruitment SWAT: Evaluation of the effects of presentation of the study design to participants on recruitment rate. Participants will be randomised to receive an infographic (visual document explaining the study) plus the standard patient information sheet (PIS) or just the PIS. 2. Retention SWAT: A 2 by 2 factorial design to simultaneously evaluate the effect of two retention strategies: a participant newsletter and a thank you card sent in advance of follow up questionnaires. Participants will be randomised to receive either: a newsletter and thank you card; a newsletter only; a thank you card only; or neither the newsletter nor the thank you card. These will be sent at Month 4 and Month 9 following randomisation to the VenUS 6 trial. Previous interventions: 3. Retention SWAT 2: The researchers will evaluate the effect of including a pen on retention rates. Participants will be randomised to receive 1) a pen; 2) no pen. These will be sent at Month 3 following randomisation to the VenUS 6 trial. Process Evaluation: Understanding participant use of compression treatments To fully understand the findings of the trial the researchers are conducting interviews to gather views and experiences on compression therapies to treat venous leg ulcers, particularly compression wraps. They will conduct semi-structured interviews of approximately 20 participants randomised to different compression treatments. The interviews will use topic guides developed from reviews of the literature on quality of life of people living with venous leg ulcers and consultations with our PPI representatives. The topic guide will explore compression adherence, ease of application, reasons for treatment change, and experiences of wearing different compression treatments. It will be iterative to allow any new themes that arise during interviews to be explored with subsequent participants. Interviews will last around an hour and will take place over telephone or preferred contact method of the participant. The researchers will also conduct up to 10 interviews with nursing staff who deliver compression treatments, as part of VenUS 6, to gather their views and experiences on treatment delivery of compression, especially compression wraps.
Intervention type	Procedure/Surgery
Primary outcome measure	Time to healing of the reference ulcer, defined as 'complete epithelial cover in the absence of a scab with no dressing required. This will be measured by blinded assessment (by two independent blinded assessors, and where there is any disagreement in review, a third review may be completed) of digital images taken at baseline and when the treating nurse regards the reference ulcer as healed
Secondary outcome measures	1. Health-related quality of life measured using the VEnous INsufficiency Epidemiological and Economic Study - Quality of Life (VEINES-QOL) and the EuroQol 5-dimension 5-level quality of life questionnaire (EQ-5D-5L) at baseline, 1, 3, 6, and 12 months 2. Resource use measured using a set of questions recording the ulcer-related care from the NHS within the past 3 months at 3, 6, and 12 months 3. Wound-related pain measured using the Visual Analogue Pain Scale (VAS) at baseline, 1, 3, 6, and 12 months 4. Participant adherence and ease of treatment use measured using a set of questions assessing views on the compression treatments, volume of treatment use, and reasons for reduced dose at 1, 3, 6 and 12 months 5. Incidence of clinical events such as reference leg healing, ulcer recurrence, amputation, admission, and discharge or death will also be recorded if and when they occur
Overall study start date	01/02/2020
Overall study end date	31/08/2024

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 675; UK Sample Size: 675
Total final enrolment	637
Participant inclusion criteria	1. ≥1 venous leg ulcer 2. Ankle:brachial pressure index (ABPI) ≥0. 8 (taken within the previous 3 months or where an ABPI is not viable, use of locally-approved alternative assessments to rule out peripheral arterial disease i.e. pulse palpation and doppler ausculation toe pressure assessment or arterial imaging also taken within the last 3 months) 3. Able to tolerate full compression 4. Aged ≥18 years
Participant exclusion criteria	1. Unwilling to wear full compression 2. Leg ulcers of non-venous aetiology (e.g. arterial or rheumatoid) 3. significant peripheral vascular disease which contraindicates full compression ( requiring an APBI of at least 0.8) 4. Ulcers confined to the foot 5. Lacks capacity or willingness to provide consent to participate in the trial 6. Currently participating in another study evaluating treatments for their venous leg ulcer 7. Known allergy to any trial product 8. Previously recruited for this trial 9. Deemed to be not clinically appropriate to take part in the trial (at clinician discretion) 10. On a waiting list for endovenous ablation and is expected to have surgery within 28 days Added 27/08/2021: 10. Planned treatment to close/remove incompetent superficial veins (e.g. via endovenous ablation, sclerotherapy) within 28 days
Recruitment start date	01/10/2020
Recruitment end date	30/04/2024

Locations

Countries of recruitment

England
United Kingdom

Study participating centres

Manchester University NHS Foundation Trust

Cobbett House
Oxford Road
Manchester
M13 9WL
United Kingdom

Leeds Community Healthcare NHS Trust

Stockdale House
8 Victoria Road
Leeds
LS6 1PF
United Kingdom

Bradford Teaching Hospitals NHS Foundation Trust

Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom

Kent Community Health NHS Foundation Trust

Unit D
The Oast
Hermitage Lane
Maidstone
ME16 9NT
United Kingdom

Lancashire & South Cumbria NHS Foundation Trust

Sceptre Point
Sceptre Way
Bamber Bridge
Preston
PR5 6AW
United Kingdom

Northumbria Healthcare NHS Foundation Trust

North Tyneside General Hospital
Rake Lane
North Shields
NE29 8NH
United Kingdom

Humber Teaching NHS Foundation Trust

Trust Hq, Willerby Hill
Beverley Road
Willerby
Hull
HU10 6ED
United Kingdom

University hospitals birmingham NHS Foundation Trust

Queen Elizabeth Hospital
Mindelsohn Way
Edgbaston
Birmingham
B15 2GW
United Kingdom

Cambridgeshire And Peterborough NHS Foundation Trust

Elizabeth House, Fulbourn Hospital
Fulbourn
Cambridge
CB21 5EF
United Kingdom

Sheffield Teaching Hospitals NHS Foundation Trust

Northern General Hospital
Herries Road
Sheffield
S5 7AU
United Kingdom

Hull University Teaching Hospitals NHS Trust

Hull Royal Infirmary
Anlaby Road
Hull
HU3 2JZ
United Kingdom

Mid Yorkshire Hospitals NHS Trust

Pinderfields Hospital
Aberford Road
Wakefield
WF1 4DG
United Kingdom

East Suffolk And North Essex NHS Foundation Trust

Colchester District General Hospital
Turner Road
Colchester
CO4 5JL
United Kingdom

Cambridgeshire Community Services NHS Trust

Unit 7/8
Meadow Park
Meadow Lane
St. Ives
PE27 4LG
United Kingdom

Norfolk Community Health And Care NHS Trust

Norwich Community Hospital
Bowthorpe Road
Norwich
NR2 3TU
United Kingdom

Derbyshire Community Health Services NHS Foundation Trust

Trust Hq, Ash Green Disability Centre
Ashgate Road
Ashgate
Chesterfield
S42 7JE
United Kingdom

Sponsor information

Manchester University NHS Foundation Trust
Hospital/treatment centre

Cobbett House
Oxford Road
Manchester
M13 9WL
England
United Kingdom

Phone	+44 (0)1612763432
Email	research.sponsor@mft.nhs.uk
Website	https://mft.nhs.uk/
"ROR"	https://ror.org/00he80998

Funders

Funder type

Government

NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: NIHR128625

No information available

National Institute for Health Research (NIHR) (UK)
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date	01/09/2025
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in publicly available repository
Publication and dissemination plan	Results from this study will be written up and submitted to peer-reviewed journals, irrespective of the magnitude or direction of effect. A publications policy will be generated in advance to detail authorship, acknowledgements and review processes for any publications arising from the VenUS 6 trial. The executive summary and copy of the trial report will be sent to the National Institute for Health and Care Excellence (NICE) and other relevant bodies, including Clinical Commissioning Groups, so that study findings can be translated into clinical practice nationally. We will also work with the relevant National Clinical Director in the Department of Health to help ensure the findings of the trial are considered when implementing policy and will work with the Speciality Advisory Committees (SAC) to incorporate the findings into the training curriculum for clinicians who will undertake treatment of venous leg ulcers. A summary of the study report will be produced and made available to participants, members of our patient advisory group and relevant patient-focused websites. Service users involved in the VenUS 6 patient advisory group will be asked to actively participate in the generation of this to ensure the results are easily accessible to patients.
IPD sharing plan	Anonymised datasets generated and analysed during the current study will be stored in a publicly available open research repository (https://osf.io/echxv). Data is anticipated to be available via this repository by the end of 2024, following the completion of analysis and subsequent publication. Sharing of this anonymised data is covered by original participant consent for the VenUS 6 trial which permits sharing of data to support future research via sharing anonymously.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article		26/05/2023	30/05/2023	Yes	No
Protocol article	process evaluation	14/11/2023	16/11/2023	Yes	No
Statistical Analysis Plan	version 1.0	24/11/2023	09/02/2024	No	No
Other files	Evidence synthesis analysis plan version 1.0	19/03/2024	04/07/2024	No	No
Other files	Health economics analysis plan version 1.0	19/03/2024	04/07/2024	No	No

Additional files

ISRCTN67321719_SAP_v1.0_24Nov2023.pdf
ISRCTN67321719 VenUS6 Synthesis analysis v1.0 19.03.2024.pdf: Evidence synthesis analysis plan
ISRCTN67321719 VenUS6 HEAP v1.0 19.03.2024.pdf: Health economics analysis plan

Editorial Notes

20/01/2025: The intention to publish date was changed from 31/01/2025 to 01/09/2025.
04/07/2024: The following changes were made to the trial record:
1. The Health economics analysis plan was uploaded as an additional file.
2. The Evidence synthesis analysis plan was uploaded as an additional file.
07/06/2024: IPD sharing plan added.
01/05/2024: Total final enrolment added.
09/02/2024: The following updates have been made:
1. The interventions were amended.
2. The public contact was replaced.
2. Statistical analysis plan added.
16/11/2023: Publication reference added.
25/07/2023: The following updates have been made:
1. The overall study end date has been changed from 31/01/2024 to 31/08/2024 and the plain English summary updated accordingly.
2. The recruitment end date has been changed from 31/03/2023 to 30/04/2024.
30/05/2023: Publication reference added.
27/08/2021: The ethics approval, interventions and exclusion criteria were updated.
08/09/2020: Trial’s existence confirmed by the National Institute for Health Research (NIHR).