The purpose of this study is to evaluate the COMS One Therapy System in combination with standard of care treatment to treat long-term diabetic foot ulcers compared to standard of care treatment alone. Changes in ulcer healing will be evaluated before, during, and after treatment with the device. The COMS One Therapy System is currently approved for use in Europe, but has not yet been approved in the US by the Food and Drug Administration (FDA); therefore, while the device is being used in the US it will be considered investigational. The study will be conducted in 15-20 sites across the US, and a total of 224 patients will be enrolled in the trial. If you decide to take part in this study, you will be assigned to one of two possible treatments.

• Active study treatment with the COMS One Therapy System and standard of care treatment

OR

• Placebo, also known as a sham device, and standard of care treatment. The Sham device was designed to look identical to the COMS One device.

Inclusion criteria:

1. Type 1 or Type 2 diabetes mellitus

2. Presence of one full-thickness diabetic foot ulcer located at or below the malleoli that does not have bone exposure and has been present for >30 days but <52 weeks

3. Adequate vascular perfusion of the target extremity

Exclusion criteria:

1. Pregnancy

2. Active skin cancer, a history of skin cancer, or any other localized skin cancer, precancerous lesions or large moles in the area to be treated

3. Currently undergoing treatment for an active systemic infection including osteomyelitis

4. End stage renal disease (requires dialysis)

5. If you are being treated with systemic corticosteroids >10mg/day for more than 10 days or any dose >30days

6. Lab values that do not meet study criteria