Table 1

Study steps and timeline

Visit number	V₁ Screening	V₂ baseline/start of treatment	V₃	V₄	V₅	V₆ final visit/end of study
Time (days)	−7/−3	0	7±2	14±2	28±2	42±3
Written informed consent	X
Demographic data	X
Vital signs (1)	X	X	X	X	X	X
Measurement of body temperature	X	X	X	X	X	X
Physical examination	X
Medical history and concomitant diseases	X
Prior and concomitant medication (2)	X	X	X	X	X	X
Urine pregnancy test (3)	X
Identification and evaluation of the target lesion	X(4)
Photo of the target lesion	X		X	X	X	X
Measurement of the area of the target lesion	X		X	X	X	X
Evaluation of the clinical signs of infection	X	X	X	X	X	X
Cleaning or medication of lesion(s)	X	X	X	X	X	X
Swab collection of the infected target lesion	X(5)			X		X
Study eligibility (inclusion and exclusion criteria)	X	X
Randomisation		X
Schedule of oxygen-ozone therapy (6)		X	X	X	X
Prescription of oral antibiotic therapy (7)		X		X
Bacteriological response				X		X
Investigator’s global assessment				X		X
Laboratory parameters	X			X		X
Assessment of compliance to antibiotics			X	X	X	X
Adverse events	X	X	X	X	X	X