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 involves at least 170 participants who will be randomly assigned to receive either the AAWD or the Aquacel Ag+ Extra wound dressing. The study focuses on treating diabetic foot ulcers and infections, aiming to assess wound healing over a 12-week period. Participants will undergo a 4-week active treatment phase where wound dressings are changed twice weekly. After this, there is an 8-week standard care period during which dressing selection and change frequency are managed by the investigator according to usual clinical practice. The two dressings being compared are both devices designed to aid wound healing. During the 12 weeks of participation, patients will be monitored through scheduled visits, laboratory sampling, and study procedures to assess wound conditions and healing progress. The primary outcome measured is the complete wound closure (CWC) at 12 weeks. Safety and adherence to treatment protocols will also be evaluated throughout the study duration.