Arcos De La Frontera

Researchers are evaluating the safety and effectiveness of the Nanordica Advanced Antibacterial Wound Dressing AAWD in patients with diabetic foot ulcers. This clinical trial compares AAWD to another wound dressing, Aquacel Ag Extra, to determine which is better at promoting wound closure. The study is randomized and double-blind, aiming to enroll at least 170 participants to address this important wound care need in diabetic patients. Participants will be randomly assigned to receive either the Nanordica AAWD or Aquacel Ag Extra wound dressing during a 4-week active treatment phase. During this phase, dressings will be changed twice weekly. Afterward, for an 8-week period, wound care will continue as standard practice, with dressing changes managed by the investigator. This design helps assess both short-term and longer-term wound healing outcomes. Throughout the 12-week study, participants will attend scheduled visits for wound assessments and laboratory tests. The main measure is complete wound closure at 12 weeks, with additional evaluations at 4 weeks, time to heal, and monitoring of adverse events. Participant safety and wound healing progress are closely followed, providing detailed information on how well the dressings perform over time.