Clinical trial NCT01421966: Evaluation of CureXcell® in Treating Lower Extremity Chronic Ulcers in Adults With Diabetes
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lower Extremity Chronic Ulcers in Diabetics
Keywords: chronic ulcers
diabetic foot ulcers
Lead sponsor: Macrocure Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Amarex Clinical Research
name: ICON plc
name: ARANZ Medical
First posted: 2011-08-23
Enrollment: 285
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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;

Primary outcomes:
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.
timeFrame: up to 20 weeks
Secondary outcomes:
measure: 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.
timeFrame: up to 20 weeks
measure: Proportion of patients with at least 50% closure of target ulcer during the 16-week core treatment period.
timeFrame: 16 weeks
measure: Proportion of patients whose Target Ulcer completely closed during the core double blind treatment phase and remained closed at the FU12 follow-up visit.
timeFrame: up to 28 weeks
Other outcomes:
Locations:
city: Glendale
country: United States
state: Arizona
city: Mesa
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Fresno
country: United States
state: California
city: San Francisco
country: United States
state: California
city: San Fransisco
country: United States
state: California
city: Sylmar
country: United States
state: California
city: Gulf Breeze
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: South Miami
country: United States
state: Florida
city: Evans
country: United States
state: Georgia
city: Arlington Heights
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Oak Park
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Wichita
country: United States
state: Kansas
city: Boston
country: United States
state: Massachusetts
city: Kansas City
country: United States
state: Missouri
city: Toms River
country: United States
state: New Jersey
city: Mineola
country: United States
state: New York
city: New York
country: United States
state: New York
city: Lima
country: United States
state: Ohio
city: Aiken
country: United States
state: South Carolina
city: Greenville
country: United States
state: South Carolina
city: Dallas
country: United States
state: Texas
city: Lewisville
country: United States
state: Texas
city: McAllen
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
city: Winnipeg
country: Canada
state: Manitoba
city: Boucherville
country: Canada
state: Quebec
city: Haifa
country: Israel
city: Holon
country: Israel
city: Jerusalem
country: Israel
city: Tel Aviv
country: Israel
Study officials:
affiliation: VA New England Health Care Division
name: Vickie Driver, MS, DPM, FACFAS
role: PRINCIPAL_INVESTIGATOR
References: