Venous leg ulcErs: management and eradication, the VEIN Platform Study

Research question

What is the optimal design and delivery strategy for a platform study evaluating the clinical and cost effectiveness of interventions for venous leg ulcer (VLU) prevention and healing? Background

VLU is the most severe manifestation of venous disease, with a prevalence of up to 4% in the elderly. Those affected have high rates of social isolation and depression with quality of life similar to end stage heart failure and increased mortality rates(2,3). VLU treatments present a tremendous burden on the healthcare service, with an estimated expenditure between £940 million and £1.3 billion per year(4).

The pathophysiology of VLU is complex. Abnormalities of the superficial and/or deep venous systems can be responsible for VLU development. Management ranges from lifestyle measures to deep venous interventions; however, systematic reviews and guidelines report that evidence is of low quality.

Where high quality evidence exists for specific interventions, healing rates and recurrence-prevention rates are still challenging to achieve(5). Numerous areas require urgent evaluation in a patient and disease-focussed process, which can potentially be delivered via a platform approach. Aims and objectives

To develop the research priorities, optimal design and infrastructure to allow the delivery of a future patient-focussed, platform trial assessing the clinical and cost-effectiveness of interventions for VLU treatment and prevention. Methods

The study will be delivered via five work streams (WS), which will: assess the evidence for VLU interventions, outcomes and comparators (WS1); establish a platform development group (PDG) with representation from patients, carers and their families, expert clinicians, industry partners, statisticians, health economists, data analytics and qualitative experts (WS2); identify key performance indicators, trial characteristics and infrastructure required to deliver the platform trial (WS3); finalise trial characteristics and implementation of platform infrastructure (WS4); finalise the funding application and trial protocol for submission (WS5). The streams will be delivered via a mixed-method approach, including evidence synthesis, interviews, questionnaires, focus groups, Delphi consensus, statistical simulation, and cost-effectiveness model scoping and simulation.

Timelines for delivery

The WS will be delivered within 9 months to inform a NIHR HTA application. The final 3 months will be used to refine the platform and proceed to a final NIHR HTA funding application. Impact and dissemination

This project will develop the first VLU platform infrastructure, which will be used in the long term for VLU trials. Information regarding the platform will be relevant to and will inform patients, the public and clinicians. Regular updates drafted by lay members of the PDG will be delivered via the Vascular Research UK website, YouTube Channel and social media to the aforementioned groups, ensuring the information is understandable.

Updates will also be provided to participating national and international bodies. The results will be presented at national and international conferences and published in peer reviewed journals. Regular updates during the study will be provided to core members of the team, with focus on patients and carers.