Designing a multi-arm, multi-stage platform trial for venous leg ulceration - Venous leg ulcers: management and eradication, the VEIN platform study.: Designing a platform/adaptive trial for venous leg ulcers (VLU) - The VEIN platform.

Background: Venous leg ulceration (VLU) is the most severe form of venous disease and an important burden to patients and society. Many treatments for VLU exist, including wound therapies, medications, and surgical interventions. However, high-level randomized trial data supporting leg ulcer treatments are lacking, limiting their adoption in clinical practice. We developed a platform trial assessing multiple interventions for VLU comprising multiple multi-arm multi-stage trials. Methods: Scoping reviews, surveys, meetings, and focus groups were conducted over five work streams to inform the development of the proposed platform trial. We involved international experts in venous disease, patients with a lived experience of VLU, healthcare professionals with an interest in VLU care, methodologists, industry partners, and other key stakeholders to help inform priority research areas and methodology, and finalize the proposed trial design. Results: Based on this feedback, the proposed multi-arm multi-stage (MAMS) platform trial will be delivered across three patient domains: patients with active ulceration present for less than six months (Domain 1), patients with active ulceration present for more than six months (Domain 2), and patients with healed ulceration (Domain 3). Interventions included wound care, medication, intervention for superficial venous reflux, and surveillance strategies delivered across community, primary, and secondary care. Conclusions: Our MAMS platform trial development highlighted many challenges and opportunities in methodology development and the potential delivery of such a study. The work performed in our work streams will help inform future research in this field.