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.
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.
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.