Low Dose Aspirin for Venous Leg Ulcers

NCT02158806 | Completed Phase 3 Results DMC

• 1 other identifier: Aspirin4VLU
• Study Type: interventional
• Target: 251
• Locations: 0 countries
• Sites: N/A

Brief Summary

Venous leg ulcers (VLU) are the most common leg ulcer, can be painful, and limit work, lifestyles and activity, especially in older patients. There are few effective treatments - compression therapy (tight bandaging or stockings) helps healing, but about half the people with a VLU remain unhealed even after 12 weeks of treatment. Research suggests taking aspirin as well as using compression may speed up healing for VLU, but the current evidence is not enough to change clinical practice. We will conduct a randomised controlled trial to test whether using low dose aspirin (150 mg daily or placebo) really does speed up healing.

Conditions

Venous Leg Ulcer

Keywords

Venous ulcer, varicose ulcer, gravitational ulcer, aspirin

Outcome Measures

Primary Outcomes (1)

• Time to Complete Healing of Reference Ulcer

  Time to event (complete healing defined as intact skin with absence of scab)

  24 weeks

Secondary Outcomes (7)

• Number of Participants With Healed Venous Leg Ulcers

  24 weeks

• Change in Estimated Ulcer Area

  Baseline, 24 weeks

• Change in Health-related Quality of Life (Short Form 36)

  Baseline, 24 weeks

• Change in Health-related Quality of Life (EuroQol-5D 3L)

  Baseline, 24 weeks

• Change in Health-related Quality of Life (Charing Cross Venous Ulcer Questionnaire)

  24 weeks

Study Arms (2)

Aspirin

EXPERIMENTAL

150 mg capsule once daily for up to 24 weeks

Drug: Aspirin

Inert capsule

PLACEBO COMPARATOR

Matching capsule once daily for up to 24 weeks

Drug: Placebo

Interventions

Aspirin DRUG

150 mg aspirin in capsule form once daily for up to 24 weeks

Aspirin

Placebo DRUG

Matching placebo capsule containing inert bulking agent

Inert capsule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or older
• Determined to have a venous leg ulcer (clinical indications of venous ulceration, Ankle Brachial Index ≥ 0.8, and other causative aetiologies ruled out)
• Able to tolerate compression therapy
• Able to provide written informed consent
• Confirmation with participant's general practitioner that the participant can take low dose aspirin or placebo.

You may not qualify if:

• Pregnant or breast-feeding women
• History of myocardial infarction, stroke, transient ischaemic attack, angina or significant peripheral arterial disease
• History of adverse effects related to aspirin use
• Currently using aspirin, or other anti-platelet or anticoagulant therapy
• Opinion of screening medical practitioner at National Institute of Health Innovation that participant has an existing condition or treatment that is a contraindication to use of aspirin or to participation in the trial.

Sponsors & Collaborators

• University of Auckland, New Zealand: lead
• Health Research Council, New Zealand: collaborator

Related Publications (2)

• Jull A, Wadham A, Bullen C, Parag V, Kerse N, Waters J. Low-dose aspirin as an adjuvant treatment for venous leg ulceration: study protocol for a randomized controlled trial (Aspirin4VLU). J Adv Nurs. 2016 Mar;72(3):669-79. doi: 10.1111/jan.12864. Epub 2015 Dec 28.

  PMID: 26708314 BACKGROUND

• Jull A, Wadham A, Bullen C, Parag V, Kerse N, Waters J. Low dose aspirin as adjuvant treatment for venous leg ulceration: pragmatic, randomised, double blind, placebo controlled trial (Aspirin4VLU). BMJ. 2017 Nov 24;359:j5157. doi: 10.1136/bmj.j5157.

  PMID: 29175902 DERIVED

MeSH Terms

Conditions

Varicose Ulcer

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

Recruitment was lower than anticipated as fewer aspirin-naive patients being available than estimated. However we had 82% power to observe the anticipated difference if assumptions had been correct.

Results Point of Contact

• Title: Professor Andrew Jull
• Organization: University of Auckland

a.jull@auckland.ac.nz

+64 9 923 4259

Study Officials

• Andrew Jull, RN PhD

  School of Nursing, University of Auckland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Identical placebo with only difference being unique code on bottle containing product.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 5, 2014
• First Posted: June 9, 2014
• Study Start: March 1, 2015
• Primary Completion: March 31, 2017
• Study Completion: March 31, 2017
• Last Updated: January 4, 2019
• Results First Posted: January 4, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: No limitations to timeframe
• Access Criteria: We have a plan to share individual participant data with other aspirin for VLU triallists. All other requests for de-identified individual participant data or study documents will be considered where the proposed use aligns with public good purposes, does not conflict with other requests, or planned use by the Trial Steering Committee, and the requestor is willing to sign a data access agreement.