Evaluation of CureXcell® in Treating Lower Extremity Chronic Ulcers in Adults With Diabetes
NCT ID: NCT01421966
Last Updated: 2015-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
285 participants
INTERVENTIONAL
2011-08-31
2015-10-31
Brief Summary
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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
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CureXcell®
CureXcell®
CureXcell® injection will be administered about every 4 weeks for up to 4 treatments, or until until ulcer closure, whichever occurs first.
Sham injection
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
Interventions
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CureXcell®
CureXcell® injection will be administered about every 4 weeks for up to 4 treatments, or until until ulcer closure, whichever occurs first.
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
Eligibility Criteria
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Inclusion Criteria
2. Patients with HbA1c ≤ 12%;
3. 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;
4. 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);
5. Ankle Brachial Index ≥ 0.65;
Exclusion Criteria
2. Patients with ulcers primarily caused by venous insufficiency;
3. Patients whose target ulcer has decreased \> 25% in size from screening to baseline;
4. Malignancy within the past 5 years excluding successfully treated basal cell carcinoma;
5. Significantly compromised immunity for any reason including radiation therapy, chemotherapy or HIV;
6. Current clinical osteomyelitis;
7. Acute Charcot foot;
8. Current sepsis;
18 Years
ALL
No
Sponsors
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Amarex Clinical Research
OTHER
ICON plc
INDUSTRY
ARANZ Medical
OTHER
Macrocure Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Vickie Driver, MS, DPM, FACFAS
Role: PRINCIPAL_INVESTIGATOR
VA New England Health Care Division
Locations
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Glendale, Arizona, United States
Mesa, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Fresno, California, United States
San Francisco, California, United States
Sylmar, California, United States
Gulf Breeze, Florida, United States
Hialeah, Florida, United States
Miami, Florida, United States
South Miami, Florida, United States
Evans, Georgia, United States
Arlington Heights, Illinois, United States
Chicago, Illinois, United States
Oak Park, Illinois, United States
Indianapolis, Indiana, United States
Wichita, Kansas, United States
Boston, Massachusetts, United States
Kansas City, Missouri, United States
Toms River, New Jersey, United States
Mineola, New York, United States
New York, New York, United States
Lima, Ohio, United States
Aiken, South Carolina, United States
Greenville, South Carolina, United States
Dallas, Texas, United States
Lewisville, Texas, United States
McAllen, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Norfolk, Virginia, United States
Winnipeg, Manitoba, Canada
Boucherville, Quebec, Canada
Haifa, , Israel
Holon, , Israel
Jerusalem, , Israel
Tel Aviv, , Israel
Countries
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Other Identifiers
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MC-102
Identifier Type: -
Identifier Source: org_study_id