Table 1.

Inclusion and exclusion criteria of the study.

Inclusion criteria
● Patients aged 20 yr or older, male or female
● Patients with diabetes mellitus type 2 (T2DM) for 3 yr or more
● Patients with diabetic ulcers <2.5 cm in diameter on the foot (corresponding to Wagner grade I and II)
● Patients with less than 1 diabetic foot ulcer located on the surface of the foot and plantar surface 30 d before the first visit
● Patients who have understood and agreed in writing to all clinical trial requirements and treatment modalities
Exclusion criteria
● Women who are currently pregnant or lactating
● Patients with ulcer area <0.25 cm2
● Patients with known or suspected systemic infection
● Patients already enrolled in another clinical trial
● Patients who have received growth factor therapy (e.g., autologous platelet plasma, stem cells, becaplermin application, cell therapy, skin substitute, amnion tissue, extracellular matrix) within 30 d of the trial registration
● Patients who received radiation or chemotherapy within 3 mo of the trial enrollment
● Patients with suspected or progressing cellulitis at the target ulcer site at first or second visit
● Patients with osteomyelitis of the foot or ankle
● For patients with a history of osteomyelitis, systemic antibacterial treatment must have been completed 60 d before the start of the trial. Patients are excluded from this study if some are administered during the trial.
● Patients with diabetic neuroarthrosis
● Patients who have difficulty participating in the trial due to the investigator judgment or other reasons
● Patients who do not intend to participate in the trial