Evaluation of CureXcell® in Treating Lower Extremity Chronic Ulcers in Adults With Diabetes
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|ClinicalTrials.gov Identifier: NCT01421966|
Recruitment Status : Completed
First Posted : August 23, 2011
Last Update Posted : December 7, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Lower Extremity Chronic Ulcers in Diabetics||Biological: CureXcell® Biological: Sham injection||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||285 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||October 2015|
CureXcell® injection will be administered about every 4 weeks for up to 4 treatments, or until until ulcer closure, whichever occurs first.
|Sham Comparator: Sham injection||
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
- Proportion of patients with complete healing/closure of their target ulcer at any time during the 16-week double-blind core treatment period with sustained complete closure for 4 additional weeks of follow-up. [ Time Frame: up to 20 weeks ]
- Time to complete closure of the Target Ulcer during the core double blind treatment phase with sustained complete closure for 4 additional weeks of follow-up. [ Time Frame: up to 20 weeks ]
- Proportion of patients with at least 50% closure of target ulcer during the 16-week core treatment period. [ Time Frame: 16 weeks ]
- Proportion of patients whose Target Ulcer completely closed during the core double blind treatment phase and remained closed at the FU12 follow-up visit. [ Time Frame: up to 28 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01421966
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|Principal Investigator:||Vickie Driver, MS, DPM, FACFAS||VA New England Health Care Division|