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 at 12 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 complete wound healing at 12 weeks post-application of the device 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 320 subjects with refractory DFU will be screened. It is expected that 30% of subjects will be excluded from the trial if either of the following occur 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).
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.