The trial design of the concurrent optical and magnetic stimulation (COMS) therapy study for refractory diabetic foot ulcers (MAVERICKS): a multicenter, randomized, sham-controlled, double-blind investigational device exemption clinical study.

Abstract

Background: Diabetic foot ulcers (DFUs) are a major clinical challenge, particularly among patients with refractory ulcers, that often lead to severe complications such as infection, amputation, and high mortality. Innovations supported by strong clinical evidence have the potential to improve healing outcomes, enhance quality of life, and reduce the economic burden on individuals and health care systems.

Objective: To describe the design of the concurrent optical and magnetic stimulation (COMS) therapy Investigational Device Exemption (IDE) study for refractory DFUs (MAVERICKS) trial.

Materials and methods: The MAVERICKS trial is a pivotal, multicenter, randomized, sham-controlled, double-blind study designed to evaluate the efficacy and safety of COMS therapy as an adjunct to standard of care for hard-to-heal DFUs. What differentiates MAVERICKS is its extended screening phase, ensuring the inclusion of truly refractory ulcers, thus addressing a critical gap in previous DFU research. With an expected enrollment of 224 patients across diverse clinical settings, the trial incorporates robust methodologies to eliminate bias, and comprehensive inclusion and exclusion criteria to ensure data integrity. The study's primary outcome measure, time to complete wound closure, as well as secondary end points including wound area reduction and time to amputation, will provide credible insights into the therapeutic potential of COMS.

Conclusion: The MAVERICKS trial is particularly significant for investigating a novel, accessible, and cost-effective approach to advance DFU treatment. This trial sets a high standard in DFU research and seeks to provide reliable evidence to improve patient outcomes and guide future clinical practice. Upon trial completion, the authors look forward to sharing the findings and outcome analysis with wound care stakeholders. The study is registered under ClinicalTrials.gov identifier NCT05758545, effective March 7, 2023.