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A Phase III Multinational, 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 Measures in Treating Lower Extremity Chronic Ulcers in Adults With Diabetes Mellitus


Phase 3
18 Years
80 Years
Open (Enrolling)
Both
Lower Extremity Chronic Ulcers in Diabetics

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Trial Information

A Phase III Multinational, 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 Measures in Treating Lower Extremity Chronic Ulcers in Adults With Diabetes Mellitus


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 III 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 375 patients, in approximately 25 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 GUC. Additional objectives are to demonstrate
safety, tolerability and durability of CureXcell™ compared to control.

The study has two phases: a core double-blind phase followed by an open-label phase. Both
phases consist of treatment and follow up periods.


Inclusion Criteria:



1. Males or females between 18 and 80 years of age (inclusive) with diabetes type 1 or
type 2;

2. Patients with HbA1c ≤ 10%;

3. Patients with at least one lower extremity ((on or below the malleoli(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 greater 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 from any reason including radiation therapy,
chemotherapy or HIV;

6. Current clinical osteomyelitis;

7. Acute Charcot foot;

8. Current sepsis;

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

up to 20 weeks

Safety Issue:

No

Principal Investigator

Richard Galperin, DPM

Investigator Role:

Principal Investigator

Investigator Affiliation:

South Hampton Community Hospital

Authority:

United States: Food and Drug Administration

Study ID:

MC-102

NCT ID:

NCT01421966

Start Date:

August 2011

Completion Date:

November 2015

Related Keywords:

  • Lower Extremity Chronic Ulcers in Diabetics
  • chronic ulcers
  • diabetic foot ulcers
  • Ulcer

Name

Location

Tufts Medical CenterBoston, Massachusetts  02111
University of MiamiMiami, Florida  33136
Southern Arizona VA Healthcare SystemTucson, Arizona  85723
Boston University Medical CenterBoston, Massachusetts  02118
Hope Research InstitutePhoenix, Arizona  
Phoenix VA Medical CenterPhoenix, Arizona  85012
Southern Arizona Limb Salvage AllianceTucson, Arizona  85723
Center for Clinical Research Inc.San Fransisco, California  94115
Barry University School of Podiatric MedicineHialeah, Florida  33013
University Hospital Center - Cancer Center Clinical Research OfficeNewark, New Jersey  07101
St. Lukes - Roosevelt Hospital CenterNew York, New York  10025
Ohio State University Comprehensive Wound CenterColumbus, Ohio  43212
Temple University School of Podiatric MedicinePhiladelphia, Pennsylvania  19107
Vascular Health AllianceGreenville, South Carolina  29615
South Hampton Community HospitalDallas, Texas  75224