Overview

This clinical trial evaluates the safety and efficacy of the Nanordica Advanced Antibacterial Wound Dressing (AAWD) in patients suffering from diabetic foot ulcers.

At least 170 participants will be randomly allocated to be treated either with AAWD or Aquacel Ag+ Extra wound dressing for a 4-week active phase (intervention) followed by an 8-week standard of care period.

Eligibility

Inclusion Criteria:

• Voluntary, written informed consent obtained prior to any study related activities.
• Males and females aged ≥18 years.
• Patients suffering DFUs for more than 4 weeks with a maximum diameter of 4 cm.
• Wound infection grades 1 (absent) or 2.
• Patients willing and able to comply with scheduled visits, laboratory sampling and study procedures.

Exclusion Criteria:

• Patients receiving systemic or topical antibiotic therapy within 7 days before the enrolment.
• Patients with any wound with known associated osteomyelitis or positive probe-to-bone test.
• Patients who have previously been randomized in this clinical trial.
• Patients who have undergone surgical procedures (e.g., radical debridement, ulcerectomy, surgical offloading, revascularization) or other advanced therapies (e.g. skin substitutes, negative pressure therapy, hyperbaric oxygen therapy) in the same leg than the index wound(s) (i.e., the ones treated and evaluated during the study) within the past four weeks, or are planned to undertake such procedures.
• Patients suffering cardiac disorders grade NYHA IV.
• Patients suffering hepatic disorders grade Child-Pugh C.
• Patients suffering advanced (stage 4) cancer.
• Patients with ankle-brachial pressure index ≤0.8 or limb peripheral arterial pressure <60 mmHg.
• Women of childbearing potential who are pregnant, breast-feeding or not using adequate contraceptive methods.