NCT01421966

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 285 (actual)
• Sponsor: Macrocure Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Lower Extremity Chronic Ulcers in Diabetics

Interventions

Type	Name	Description
BIOLOGICAL	CureXcell®	CureXcell® injection will be administered about every 4 weeks for up to 4 treatments, or until until ulcer closure, whichever occurs first.
BIOLOGICAL	Sham injection	The sham injections will be made by pressing on the ulcer with a needle connected to an empty syringe, at each cm of the ulcer bed

Timeline

• Start date: 2011-08-01
• Primary completion: 2015-02-01
• Completion: 2015-10-01
• First posted: 2011-08-23
• Last updated: 2015-12-07

Locations

37 sites across 3 countries: United States, Canada, Israel