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

Diabetic Foot Ulcer Clinical Trial

Official title:
Concurrent Optical and Magnetic Stimulation (COMS) for Treatment of Refractory Diabetic Foot Ulcer; a Prospective Randomized, Sham-controlled, Double-blinded, Pivotal Clinical Trial

Clinical Trial Summary

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.

Clinical Trial Description

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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05758545
Study type Interventional
Source Piomic Medical
Contact Rejelle Williams
Phone +41 44 244 19 78
Email williams@piomic.com
Status Recruiting
Phase N/A
Start date June 19, 2023
Completion date June 19, 2025
View Details
See also
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