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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01421966
Recruitment Status : Completed
First Posted : August 23, 2011
Last Update Posted : December 7, 2015
Sponsor:
Collaborators:
Amarex Clinical Research
ICON plc
ARANZ Medical
Information provided by (Responsible Party):
Macrocure Ltd.

Study Description
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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.


Condition or disease Intervention/treatment Phase
Lower Extremity Chronic Ulcers in Diabetics Biological: CureXcell® Biological: Sham injection Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 285 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

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Arms and Interventions
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Arm Intervention/treatment
Experimental: CureXcell® Biological: CureXcell®
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


Outcome Measures
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Primary Outcome Measures :
  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. [ Time Frame: up to 20 weeks ]

Secondary Outcome Measures :
  1. 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 ]
  2. Proportion of patients with at least 50% closure of target ulcer during the 16-week core treatment period. [ Time Frame: 16 weeks ]
  3. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males or females at least 18 years of age with diabetes type 1 or type 2;
  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:

  1. Patients with more than two ulcers on the same foot or more than a total of three chronic ulcers;
  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;
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Arizona
Glendale, Arizona, United States
Mesa, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
United States, California
Fresno, California, United States
San Francisco, California, United States
San Fransisco, California, United States
Sylmar, California, United States
United States, Florida
Gulf Breeze, Florida, United States
Hialeah, Florida, United States
Miami, Florida, United States
South Miami, Florida, United States
United States, Georgia
Evans, Georgia, United States
United States, Illinois
Arlington Heights, Illinois, United States
Chicago, Illinois, United States
Oak Park, Illinois, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Kansas
Wichita, Kansas, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Missouri
Kansas City, Missouri, United States
United States, New Jersey
Toms River, New Jersey, United States
United States, New York
Mineola, New York, United States
New York, New York, United States
United States, Ohio
Lima, Ohio, United States
United States, South Carolina
Aiken, South Carolina, United States
Greenville, South Carolina, United States
United States, Texas
Dallas, Texas, United States
Lewisville, Texas, United States
McAllen, Texas, United States
San Antonio, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Virginia
Norfolk, Virginia, United States
Canada, Manitoba
Winnipeg, Manitoba, Canada
Canada, Quebec
Boucherville, Quebec, Canada
Israel
Haifa, Israel
Holon, Israel
Jerusalem, Israel
Tel Aviv, Israel
Sponsors and Collaborators
Macrocure Ltd.
Amarex Clinical Research
ICON plc
ARANZ Medical
Investigators
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Principal Investigator: Vickie Driver, MS, DPM, FACFAS VA New England Health Care Division
More Information
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Responsible Party: Macrocure Ltd.
ClinicalTrials.gov Identifier: NCT01421966    
Other Study ID Numbers: MC-102
First Posted: August 23, 2011    Key Record Dates
Last Update Posted: December 7, 2015
Last Verified: December 2015
Keywords provided by Macrocure Ltd.:
chronic ulcers
diabetic foot ulcers
Additional relevant MeSH terms:
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Ulcer
Pathologic Processes