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First received: February 09, 2023

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

Study Status: Completed

Recruit Status: RECRUITING

Condition: Diabetic Foot Ulcer

Study Type: INTERVENTIONAL


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

Brief 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.

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