Clinical Trials

Mild Infections of Diabetic Foot Ulcers

We are conducting two pivotal Phase 3 clinical trials in Mild DFI, OneStep-1 and OneStep-2. These trials are designed to establish the clinical superiority and safety of Locilex® plus standard local wound care (debridement and off-loading) as compared to placebo cream plus standard local wound care, in the treatment of Mild DFI. Through a Special Protocol Assessment (or SPA) agreement, the U.S. Food and Drug Administration (FDA), has agreed that the design and planned analyses of our pivotal Phase 3 program adequately address objectives in support of a New Drug Application for Locilex®.

For more information on OneStep-1 and OneStep-2, please visit clinicaltrials.gov:

OneStep-1: A Randomized, Double-Blind, Multicenter, Superiority, Placebo-Controlled Phase 3 Study of Pexiganan Cream 0.8% Applied Twice Daily for 14 in the Treatment of Adults With Mild Infections of Diabetic Foot Ulcers

OneStep-2: A Randomized, Double-Blind, Multicenter, Superiority, Placebo-Controlled Phase 3 Study of Pexiganan Cream 0.8% Applied Twice Daily for 14 in the Treatment of Adults With Mild Infections of Diabetic Foot Ulcers

For more information on Special Protocol Assessments, please click here.