Clinical evaluation of a first-in-class antibacterial wound dressing with copper and silver nanoparticles in patients with infected diabetic foot ulcers

Introduction: Diabetic foot ulcers (DFUs) pose significant challenges to healthcare systems worldwide, with few effective treatment options recommended by international guidelines.  The role of wound dressings in treating infected DFUs remains unclear.  This clinical trial investigated a first-in-class wound dressing utilizing synergistic copper and silver nanoparticles (CuAgWD), comparing it to a commercially available gelling fiber silver ion dressing (AgWD), to assess its efficacy and safety in infected DFUs.Methods: This randomized single-center parallel-group clinical trial enrolled 30 patients with grade 2 DFU infections as per IWGDF guidelines. Patients were randomly assigned to CuAgWD or AgWD. The primary objective was to compare the safety and efficacy of CuAgWD to AgWD in treating infected DFUs. Secondary objectives included comparing changes in wound appearance and patient quality of life (QoL).Results:The trial demonstrated a nearly two-fold greater reduction in wound area size (WAS) in the CuAgWD group compared to the AgWD group after one week of active treatment and two weeks of follow-up. Statistical modeling allowed to extrapolate the effects beyond the period observed in the study, showing that the time required to achieve a 50% WAS reduction was nearly double in the AgWD group (about 37 days) than in the CuAgWD group (about 21 days). Bacterial loads remained stable in both groups, with a trend towards reduction during the active phase with CuAgWD. Importantly, CuAgWD was associated with greater improvements in wound edge redness, swelling, exudate quantity, quality of life scores, and a lower prevalence of adverse events.Discussion: CuAgWD proved to be a feasible treatment for infected DFUs, showing good tolerability and consistently better results in nearly all efficacy and safety parameters compared to currently available antibacterial silver ion-based dressing.References: