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

Purpose

The purpose of this study is to evaluate the safety and effectiveness of the treatment with the COMS One device in subjects with refractory diabetic foot ulcers (DFUs). 

The duration of this study will last up to 28 weeks. 

Could this study be right for you?

Inclusion

• Male and females aged 22 to 90 years old 
• Able to understand and sign the informed consent form (ICF) and comply with requirements set in the protocol including trial visits, trial treatment and dressing regimens and compliance with required offloading device (if applicable)
• Type 1 or Type 2 diabetes mellitus

Exclusion

• Known pregnancy or lactating
• Active skin cancer, a history of skin cancer or any other localized cancer, precancerous lesions or large moles in the areas to be treated
   

Inclusion and Exclusion Criteria varies, please contact Study Coordinator for more information. 

Age Range

22 - 90 years