Local Application of Combined Optical and Magnetic Stimulation (COMS) for Treatment of Chronic Wounds: Safety Evaluation

Incidence of adverse event

The incidence of adverse events will be assessed at each visit, prior to the Pio treatment and directly after the Pio treatment. The incidence of treatment-emergent adverse events will be compared to the incidence of standard of care emergent adverse events.

Time frame: At each visit, up to 16 weeks

Severity of adverse event

The severity of adverse events will be assessed at each visit, prior to the Pio treatment and directly after the Pio treatment. The severity of treatment-emergent adverse events will be compared to the severity of standard of care emergent adverse events.

Time frame: At each visit, up to 16 weeks

Time of occurrence of adverse event

The time of occurrence of adverse events will be assessed at each visit, prior to the Pio treatment and directly after the Pio treatment. The time of occurrence of treatment-emergent adverse events will be compared to the time of occurrence of standard of care emergent adverse events.

Time frame: At each visit, up to 16 weeks

Type of adverse event

The type of adverse events will be assessed at each visit, prior to the Pio treatment and directly after the Pio treatment. The type of treatment-emergent adverse events will be compared to the type of standard of care emergent adverse events.

Time frame: At each visit, up to 16 weeks