Clinical Research Directory

Inclusion Criteria: * Voluntary, written informed consent obtained prior to any study related activities. * Males and females aged ≥18 years. * DFU(s) present for more than 4 weeks with a maximum diameter of 4 cm. * IWGDF/IDSA Wound infection grades 1 (absent) or 2. * Patients willing and able to comply with scheduled visits, laboratory sampling and study procedures. * Ankle-brachial index (ABI) 0.9-1.4 or ABI between 0.6-0.9 with ankle pressure ≥ 70 mmHg. Exclusion Criteria: * Ssystemic or topical antibiotic therapy within 7 days before the enrolment. * Any wound with known associated osteomyelitis or positive probe-to-bone test. * Previous randomization in this clinical trial. * Surgical procedures in the same leg as the index ulcer(s) (e.g., radical debridement, ulcerectomy, skin grafting, exostectomy, amputation) within the past four weeks, or planned to during the study. * Use of other advanced therapies directly involving the index ulcer(s) (e.g. skin substitutes, matrices, cellbased therapies or products) within the past four weeks. * Patients suffering cardiac disorders grade NYHA IV. * Patients suffering hepatic disorders grade Child-Pugh C. * Stage 4 cancer. * Women of childbearing potential who are pregnant, breast-feeding or not using adequate contraceptive methods.