Venous Leg UlcerPhase 2AVURTNCT02333123
Aspirin for Venous Ulcers: Randomised Trial (AVURT)
A Phase 2 study testing Aspirin in people with Venous Leg Ulcer, run by St George's, University of London at 5 sites in United Kingdom.
Trial summary
This efficacy study evaluates the safety and effectiveness of aspirin for venous leg ulcer healing. The study also examines whether patients can be recruited to a larger study. Patients with chronic venous leg ulceration presenting and undergoing care in leg ulcer community clinics or hospital out-patient clinics, or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer
- What is being tested?
- Aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- 10 Jul 2015to 11 Nov 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those with at least one chronic venous leg ulcer - where chronic venous leg ulceration is defined as any break in the skin which has either: a) been present for more than six weeks, or b) occurred in a person with a history of venous leg ulceration. Ulcers will be considered purely venous if clinically no other etiology was suspected. For this the ulcer must be venous in appearance (i.e. moist, shallow, of an irregular shape) and lie wholly or partially within the gaiter region of the leg. If the patient has more than one ulcer we will choose the largest ulcer as the 'index' lesion for purposes of the analysis.
- Ulcer area > 1 square cm
- Participants must have had an ankle brachial pressure index (ABPI) ≥ 0.8 taken within the previous three months. When the ABPI is incompressible other forms of assessment including peripheral pulse examination / toe pressure / duplex ultrasound in combination with clinical judgement to be used to exclude PAD
- Aged ≥ 18 years (no upper age limit)
- Able and willing to provide informed consent
- Ulcer duration > 6 weeks or prior history of venous ulceration.
Who cannot join
- Unable to provide consent
- Unwilling to provide consent
- Foot (below the ankle) ulcer
- A leg ulcer of non-venous aetiology (i.e. arterial)
- Ankle-brachial pressure index (ABPI) <0.8
- Current regular use of aspirin (as may be randomised to placebo)
Show all 13Show fewer
- Previous intolerance of aspirin / contraindication to aspirin (decision made according to the prescribers' clinical judgement)
- Prohibited medication: Probenecid
- Known lactose intolerance (as placebo contains lactose)
- Pregnant/lactating women
- Currently participating in another study evaluating leg ulcer therapies.
- Another reason that excluded them from participating within this trial (decision made according to the nurses' or prescribers' clinical judgment )*
- Previously been recruited in to this trial.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
Brighton General Hosp
Brighton, Sussex, BN2 3EW
Hull & East Yorkshire Hospital NHS Trust
Cottingham, Castle Hill Hosp, HU16 5JP
Harrogate & district NHS Trust
Harrogate, N.Yorkshire
Freeman Hospital
Newcastle upon Tyne, NE3 3HD
St George's University Hospitals NHS Foundation Trust
Tooting, London, SW17 0QT
About this study
This efficacy study evaluates the safety and effectiveness of aspirin for venous leg ulcer healing. The study also examines whether patients can be recruited to a larger study. Patients with chronic venous leg ulceration presenting and undergoing care in leg ulcer community clinics or hospital out-patient clinics, or registered with a clinic but are receiving care at home will be recruited. All patients will receive standard compression bandaging. Half of the participants will be randomised to receive aspirin, while the other half will receive a placebo.
Read the detailed description
The mainstay of treatment of leg ulcers is graded compression therapy to squeeze the fluid out of the leg and venous system. This has been shown to be effective in many clinical trials. However, despite this treatment patients take many months to heal (with median healing times of approximately 12 weeks in previous trials) and for some patients compression therapy does not result in resolution of their leg ulcers. The use of compression (as well as dressings largely to manage the wound exudate) can be expensive as nurse time is required to change bandages which can be required weekly or more frequently. Furthermore, for many patients the compression therapy is uncomfortable (sometimes painful) and inconvenient for everyday life (compression is bulky and dressings have to be changed several times weekly). If other treatments were able to reduce the time to healing then this would be a significant breakthrough.
Results from two earlier small trials suggest aspirin may be of benefit. However this trials were poorly designed and reported. The present study will evaluate whether the addition of 300mg of daily aspirin to standard evidence based therapies reduces the time to healing of chronic venous leg ulceration using a more rigorous design. The study will also establish the feasibility of satisfactory participant recruitment for a bigger trial, and whether participants are compliant with their aspirin therapy. The safety of aspirin in this patient population will also be monitored.
- Conditions
- Venous Leg Ulcer
- Being tested
- Aspirin, Placebo (for Aspirin)
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Each 300mg aspirin capsule will contain over-encapsulated 4 x Aspirin 75mg tablets.
Placebo (for Aspirin)Drug
Each placebo capsule will contain a lactose and magnesium stearate blend, and will appear identical in weight, colour and size to the matched aspirin capsules.
| Study group | Role | What they receive |
|---|---|---|
| Aspirin | Experimental | Aspirin 300mg capsule by mouth once a day for 24 weeks. Receives: Drug: Aspirin |
| Placebo | Placebo comparator | Placebo capsule (for aspirin 300mg capsule) by mouth once a day for 24 weeks. Receives: Drug: Placebo (for Aspirin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to healing of the reference ulcer (the largest eligible ulcer)
Measured: 25 weeks
Secondary outcomes (6)
Ulcer size (area) measured in square cm
Measured: 25 weeks
Recurrence of reference ulcer
Proportion of participants with a recurrence of reference ulcer. Time to recurrence.
Measured: 25 weeks
Ulcer related pain using the VAS Score
Measured: 5 weeks
Treatment concordance: number of participants completing the course of treatment
Proportion of participants completing the course of treatment up to healing or planned trial exit. The number of capsules taken. Nurse's assessment of participant's compliance with recommended compression therapy.
Measured: 24 weeks
Resource use
Number and duration of all leg ulcer-related appointments with health professionals (including wound related in-patient stays ). Number of and types of dressings used.
Measured: 27 weeks
Number of adverse events
Number of participants with at least one event. Total number of events.
Measured: 27 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study start10 Jul 2015
- Primary completion18 Aug 2016
- Study completion11 Nov 2016
Why it stopped: Recruitment halted following TSC meeting due to poor recruitment and study unlikely to complete. Funders withdrew continued support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Venous Leg UlcerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Collaborators
- University of York, University of Manchester, Bradford Teaching Hospitals NHS Foundation Trust, Harrogate & District NHS Foundation Trust, Hull University Teaching Hospitals NHS Trust, University of Nottingham, Cardiff University, University of Newcastle Upon-Tyne
- Responsible party
- Sponsor
- Investigators
- Robert J Hinchliffe, MD, FRCS, Principal investigator, St George's Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02333123
- Sponsor's protocol ID
- 14.0096
- Acronym
- AVURT
- Status last verified
- Jun 2017
- First submitted
- 5 Nov 2014
- Last updated
- 27 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Helen T, Liz C, Laura C, Illary S, Martin B, Hannah B, Ian C, Jo D, Chris F, Rachael F, Rhian G, Keith H, Alison L, Ellie L, Catriona MD, Christine M, Debbie R, Gerard S, David T, Peter V, Laurie W, Robert H. Aspirin versus placebo for the treatment of venous leg ulcers-a phase II, pilot, randomised trial (AVURT). Trials. 2019 Jul 26;20(1):459. doi: 10.1186/s13063-019-3480-7.
PubMed 31349862Tilbrook H, Clark L, Cook L, Bland M, Buckley H, Chetter I, Dumville J, Fenner C, Forsythe R, Gabe R, Harding K, Layton A, Lindsay E, McDaid C, Moffatt C, Rolfe D, Sbizzera I, Stansby G, Torgerson D, Vowden P, Williams L, Hinchliffe R. AVURT: aspirin versus placebo for the treatment of venous leg ulcers - a Phase II pilot randomised controlled trial. Health Technol Assess. 2018 Oct;22(55):1-138. doi: 10.3310/hta22550.
PubMed 30325305Tilbrook H, Forsythe RO, Rolfe D, Clark L, Bland M, Buckley H, Chetter I, Cook L, Dumville J, Gabe R, Harding K, Layton A, Lindsay E, McDaid C, Moffatt C, Phillips C, Stansby G, Vowden P, Williams L, Torgerson D, Hinchliffe RJ. Aspirin for Venous Ulcers: Randomised Trial (AVURT): study protocol for a randomised controlled trial. Trials. 2015 Nov 10;16:513. doi: 10.1186/s13063-015-1039-9.
PubMed 26554558
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspirin for Venous Ulcers: Randomised Trial (AVURT)
- ClinicalTrials.gov ID
- NCT02333123
- Acronym / sponsor ID
- AVURT / 14.0096
- Conditions
- Venous Leg Ulcer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment halted following TSC meeting due to poor recruitment and study unlikely to complete. Funders withdrew continued support
- Enrolment
- 26 participants (actual)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Collaborators
- University of York, University of Manchester, Bradford Teaching Hospitals NHS Foundation Trust, Harrogate & District NHS Foundation Trust, Hull University Teaching Hospitals NHS Trust, University of Nottingham, Cardiff University, University of Newcastle Upon-Tyne
- Study start
- 10 Jul 2015 (actual)
- Primary completion
- 18 Aug 2016 (actual)
- Study completion
- 11 Nov 2016 (actual)
- First posted
- 7 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This efficacy study evaluates the safety and effectiveness of aspirin for venous leg ulcer healing. The study also examines whether patients can be recruited to a larger study. Patients with chronic venous leg ulceration presenting and undergoing care in leg ulcer community clinics or hospital out-patient clinics, or registered with a clinic but are receiving care at home will be recruited. All patients will receive standard compression bandaging. Half of the participants will be randomised to receive aspirin, while the other half will receive a placebo.
Detailed description
The mainstay of treatment of leg ulcers is graded compression therapy to squeeze the fluid out of the leg and venous system. This has been shown to be effective in many clinical trials. However, despite this treatment patients take many months to heal (with median healing times of approximately 12 weeks in previous trials) and for some patients compression therapy does not result in resolution of their leg ulcers. The use of compression (as well as dressings largely to manage the wound exudate) can be expensive as nurse time is required to change bandages which can be required weekly or more frequently. Furthermore, for many patients the compression therapy is uncomfortable (sometimes painful) and inconvenient for everyday life (compression is bulky and dressings have to be changed several times weekly). If other treatments were able to reduce the time to healing then this would be a significant breakthrough.
Results from two earlier small trials suggest aspirin may be of benefit. However this trials were poorly designed and reported. The present study will evaluate whether the addition of 300mg of daily aspirin to standard evidence based therapies reduces the time to healing of chronic venous leg ulceration using a more rigorous design. The study will also establish the feasibility of satisfactory participant recruitment for a bigger trial, and whether participants are compliant with their aspirin therapy. The safety of aspirin in this patient population will also be monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin | Experimental | Drug: AspirinAspirin 300mg capsule by mouth once a day for 24 weeks. |
| Placebo | Placebo comparator | Drug: Placebo (for Aspirin)Placebo capsule (for aspirin 300mg capsule) by mouth once a day for 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Those with at least one chronic venous leg ulcer - where chronic venous leg ulceration is defined as any break in the skin which has either: a) been present for more than six weeks, or b) occurred in a person with a history of venous leg ulceration. Ulcers will be considered purely venous if clinically no other etiology was suspected. For this the ulcer must be venous in appearance (i.e. moist, shallow, of an irregular shape) and lie wholly or partially within the gaiter region of the leg. If the patient has more than one ulcer we will choose the largest ulcer as the 'index' lesion for purposes of the analysis.
- Ulcer area > 1 square cm
- Participants must have had an ankle brachial pressure index (ABPI) ≥ 0.8 taken within the previous three months. When the ABPI is incompressible other forms of assessment including peripheral pulse examination / toe pressure / duplex ultrasound in combination with clinical judgement to be used to exclude PAD
- Aged ≥ 18 years (no upper age limit)
- Able and willing to provide informed consent
Key exclusion criteria (13 listed)
- Unable to provide consent
- Unwilling to provide consent
- Foot (below the ankle) ulcer
- A leg ulcer of non-venous aetiology (i.e. arterial)
- Ankle-brachial pressure index (ABPI) <0.8
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 |
|---|---|---|
| AspirinEach 300mg aspirin capsule will contain over-encapsulated 4 x Aspirin 75mg tablets. | Drug | Aspirin |
| Placebo (for Aspirin)Each placebo capsule will contain a lactose and magnesium stearate blend, and will appear identical in weight, colour and size to the matched aspirin capsules. | Drug | Placebo |
Primary outcome
Time to healing of the reference ulcer (the largest eligible ulcer)
Time frame: 25 weeks
6 secondary outcomes
Ulcer size (area) measured in square cm
Time frame: 25 weeks
Recurrence of reference ulcer
Time frame: 25 weeks
Ulcer related pain using the VAS Score
Time frame: 5 weeks
Treatment concordance: number of participants completing the course of treatment
Time frame: 24 weeks
Resource use
Time frame: 27 weeks
Number of adverse events
Time frame: 27 weeks
Results and safety
The study was stopped early (reason given: Recruitment halted following TSC meeting due to poor recruitment and study unlikely to complete. Funders withdrew continued support). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2017.
- Derived from this study: PubMed 31349862Helen T, Liz C, Laura C, Illary S, Martin B, Hannah B, Ian C, Jo D, Chris F, Rachael F, Rhian G, Keith H, Alison L, Ellie L, Catriona MD, Christine M, Debbie R, Gerard S, David T, Peter V, Laurie W, Robert H. Aspirin versus placebo for the treatment of venous leg ulcers-a phase II, pilot, randomised trial (AVURT). Trials. 2019 Jul 26;20(1):459. doi: 10.1186/s13063-019-3480-7.
- Derived from this study: PubMed 30325305Tilbrook H, Clark L, Cook L, Bland M, Buckley H, Chetter I, Dumville J, Fenner C, Forsythe R, Gabe R, Harding K, Layton A, Lindsay E, McDaid C, Moffatt C, Rolfe D, Sbizzera I, Stansby G, Torgerson D, Vowden P, Williams L, Hinchliffe R. AVURT: aspirin versus placebo for the treatment of venous leg ulcers - a Phase II pilot randomised controlled trial. Health Technol Assess. 2018 Oct;22(55):1-138. doi: 10.3310/hta22550.
- Derived from this study: PubMed 26554558Tilbrook H, Forsythe RO, Rolfe D, Clark L, Bland M, Buckley H, Chetter I, Cook L, Dumville J, Gabe R, Harding K, Layton A, Lindsay E, McDaid C, Moffatt C, Phillips C, Stansby G, Vowden P, Williams L, Torgerson D, Hinchliffe RJ. Aspirin for Venous Ulcers: Randomised Trial (AVURT): study protocol for a randomised controlled trial. Trials. 2015 Nov 10;16:513. doi: 10.1186/s13063-015-1039-9.
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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.
Robert J Hinchliffe, MD, FRCS principal investigator
St George's Healthcare NHS Trust
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aspirin in people with Venous Leg Ulcer, run by St George's, University of London at 5 sites 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 6 inclusion and 13 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: stopped early, as of the sponsor's last update on 27 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Recruitment halted following TSC meeting due to poor recruitment and study unlikely to complete. Funders withdrew continued support). Results are not available in the source record.
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?
Time to healing of the reference ulcer (the largest eligible ulcer) (time frame: 25 weeks). 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 NCT02333123, which also lists 3 linked publications.
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 27 Jun 2017.