Randomized Double-Blind Trial on Safety and Efficacy of Nanordica Advanced Antibacterial Wound Dressing for Diabetic Foot Ulcer

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.