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
1 other identifier
interventional
285
3 countries
37
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2011
Typical duration for phase_3
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 21, 2011
CompletedFirst Posted
Study publicly available on registry
August 23, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedDecember 7, 2015
December 1, 2015
3.5 years
August 21, 2011
December 3, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
up to 20 weeks
Secondary Outcomes (3)
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.
up to 20 weeks
Proportion of patients with at least 50% closure of target ulcer during the 16-week core treatment period.
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.
up to 28 weeks
Study Arms (2)
CureXcell®
EXPERIMENTALSham injection
SHAM COMPARATORInterventions
CureXcell® injection will be administered about every 4 weeks for up to 4 treatments, or until until ulcer closure, whichever occurs first.
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
Eligibility Criteria
You may qualify if:
- Males or females at least 18 years of age with diabetes type 1 or type 2;
- Patients with HbA1c ≤ 12%;
- Patients with at least one lower extremity (on or below the malleolus (ankle bone)), at least full-thickness ulcer (penetrating through the whole layer of the skin), which has been unresponsive to any treatment for at least 4 weeks;
- Ulcers with an area between ≥ 1 cm2 and ≤ 20 cm2 (after sharp debridement of free, non-viable, hyperkeratotic and fibrotic tissue to the extent possible);
- Ankle Brachial Index ≥ 0.65;
You may not qualify if:
- Patients with more than two ulcers on the same foot or more than a total of three chronic ulcers;
- Patients with ulcers primarily caused by venous insufficiency;
- Patients whose target ulcer has decreased \> 25% in size from screening to baseline;
- Malignancy within the past 5 years excluding successfully treated basal cell carcinoma;
- Significantly compromised immunity for any reason including radiation therapy, chemotherapy or HIV;
- Current clinical osteomyelitis;
- Acute Charcot foot;
- Current sepsis;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Macrocure Ltd.lead
- Amarex Clinical Researchcollaborator
- ICON plccollaborator
- ARANZ Medicalcollaborator
Study Sites (37)
Unknown Facility
Glendale, Arizona, United States
Unknown Facility
Mesa, Arizona, United States
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
Fresno, California, United States
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San Francisco, California, United States
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Sylmar, California, United States
Unknown Facility
Gulf Breeze, Florida, United States
Unknown Facility
Hialeah, Florida, United States
Unknown Facility
Miami, Florida, United States
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South Miami, Florida, United States
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Evans, Georgia, United States
Unknown Facility
Arlington Heights, Illinois, United States
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Chicago, Illinois, United States
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Oak Park, Illinois, United States
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Indianapolis, Indiana, United States
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Wichita, Kansas, United States
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Boston, Massachusetts, United States
Unknown Facility
Kansas City, Missouri, United States
Unknown Facility
Toms River, New Jersey, United States
Unknown Facility
Mineola, New York, United States
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New York, New York, United States
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Lima, Ohio, United States
Unknown Facility
Aiken, South Carolina, United States
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Greenville, South Carolina, United States
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Dallas, Texas, United States
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Lewisville, Texas, United States
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McAllen, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Norfolk, Virginia, United States
Unknown Facility
Winnipeg, Manitoba, Canada
Unknown Facility
Boucherville, Quebec, Canada
Unknown Facility
Haifa, Israel
Unknown Facility
Holon, Israel
Unknown Facility
Jerusalem, Israel
Unknown Facility
Tel Aviv, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vickie Driver, MS, DPM, FACFAS
VA New England Health Care Division
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2011
First Posted
August 23, 2011
Study Start
August 1, 2011
Primary Completion
February 1, 2015
Study Completion
October 1, 2015
Last Updated
December 7, 2015
Record last verified: 2015-12