Lower Extremity Chronic Ulcers in Diabetics Clinical Trial
Official title:
A Phase III Multicenter, Randomized, Double-Blind, Parallel-Group, Sham-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of CureXcell® as an Adjunct to Good Wound Care in Lower Extremity Chronic Ulcers in Adults With Diabetes Mellitus
Chronic foot ulcers are particularly prevalent in patients with underlying diabetes
mellitus. These ulcers are reported to be the leading cause of hospitalization among people
with diabetes.
The purpose of this study is to evaluate CureXcell® in treating chronic lower extremity
ulcers in adults with diabetes mellitus. CureXcell® is a cell based therapy, containing
activated homologous white blood cells prepared from donated healthy whole blood. A total of
280 patients will be randomized to receive either CureXcell® or sham.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment