Trial to Evaluate the Safety and Effectiveness of Treatment With COMS One Device in Subjects With Diabetic Foot Ulcers

The purpose of this clinical trial is to evaluate the safety and effectiveness of the treatment with the COMS One device in subjects with refractory diabetic foot ulcers (DFUs). The prospective randomized, double-blinded, sham-controlled trial is designed to demonstrate superiority of wound closure of the COMS One device to a sham-control device through 24 weeks post-application, when each is administered in conjunction with standard of care (SOC) in the treatment of DFUs. Primary Objective: The COMS One Therapy System is intended to promote wound healing in chronic DFUs. As part of the clinical investigation, the primary objective is to determine time to complete wound healing, defined as complete skin re-epithelialization without drainage confirmed by 2 consecutive trial visits 2 weeks apart. Secondary Objectives: Secondary objectives are confirmation of safety and assessment of wound healing parameters as well as subject and site reported outcomes. A total of 450 subjects with refractory DFU will be screened. It is expected that 50% of subjects will be excluded from the trial if either of the following occurs between screening and randomization: \>30% wound closure over a period of 2 weeks or \>50% wound closure over a period of 4 weeks (measured post-debridement). The remaining 224 subjects will be randomized into two groups (112 Subjects Sham device treated; 112 Subjects COMS One device treated) to account for approximately 10% missing data due to early trial withdrawal or missed endpoint assessment.