The demographic characteristics associated with the primary composite outcome were age over 60 years, duration of diabetes over 10 years, ulcer area larger than 10 cm2, depth of the lesion according to Wagner classification [20], infection grade according to IDSA [10], presence of peripheral arterial disease, San Elian score ≥ 20 [15], hemoglobin <10 g/dl, albumin <3.5 g/dl, HbA1c ≥7%, and polymicrobial culture (Table 4). This evidence concerns the gene ALB and infection.