Lakewood-Amedex Begins Phase 2a Trial for Diabetic Foot Ulcer Treatment

The multicenter, single-blinded study tests three concentrations of the topical gel—2%, 5%, and 10%—to determine the optimal dosage for future clinical development. By targeting microbial burdens directly at the wound site, Nu-3 is designed to circumvent the limitations of conventional antibiotics and address the growing threat of antimicrobial resistance. The company expects to release topline data from this trial in the first quarter of 2027.

Dr. David G. Armstrong, the study chair and a professor at the Keck School of Medicine of USC, emphasized that the trial addresses a critical gap in wound care. As antimicrobial resistance renders standard infections increasingly difficult to manage, local delivery systems like Nu-3 offer a potential alternative to preserve limbs and improve patient outcomes. The trial is being managed by the Professional Education and Research Institute, which will oversee patient recruitment across a network of clinical sites.