Safety and Efficacy of Cell-Free Amniotic Fluid (cfAF) Injections in the Treatment of Chronic, Non-Healing Venous Ulcers: Initial Experience from a Prospective, Multicenter, Phase 2 Study

Introduction: Treatment of chronic non-healing and/or recurrent venous leg ulcers (VLU) represents a significant healthcare problem. Persistent symptomatology despite correction of underlying hemodynamic pathophysiology and standard of care (SOC) treatment of the wound results in a substantial reduction of quality of life and imposes a significant economic burden on society due to increased healthcare costs and decreased productivity. The objective of this study is to assess the safety and efficacy of cell-free amniotic fluid (cfAF) injectables in the treatment of VLUs refractory to SOC treatment.   Methods: Methods. This is a prospective, multicenter, two-part, Phase 2 study (NCT04647240) of patients with non-healing, non-infected, refractory to SOC VLUs (ulcers size