Evaluation of CureXcell® in Treating Lower Extremity Chronic Ulcers in Adults With Diabetes

Chronic foot ulcers are particularly prevalent in patients with underlying diabetes mellitus. The prevalence of diabetes mellitus is growing at epidemic rates in Europe, United States and in general worldwide. Foot ulceration is a serious complication of diabetes mellitus associated with increased risk of infection, gangrene and amputation. These ulcers are reported to be the leading cause of hospitalization among people with diabetes. Despite existing ulcer therapies and technologies, there continues to be a great necessity for new wound healing technologies that will further improve healing rates for these chronic ulcers that remain a major source of morbidity, concern, and cost. This Phase 3 multinational, multicenter, randomized, double-blind, controlled study is designed to evaluate CureXcell® in treating lower extremity chronic ulcers in adults with Diabetes Mellitus. CureXcell® is a cell based therapy obtained from donated whole blood. The blood are collected from healthy, young adult (age 18-40), the cells separated and then activated by hypo-osmotic shock. A total of 280 patients, in approximately 35 sites in the US, Canada and Israel, will be randomized to receive either CureXcell® or control. The primary objective of the study is to evaluate the clinical benefit of CureXcell® (study biologic) compared to control, as adjunct to Good Ulcer Care. Additional objectives are to demonstrate safety, tolerability and durability of CureXcell® compared to control. The study has two phases: a core double-blind phase and a follow up phase.