Clinical trial NCT02130310: Evaluation of CureXcell® in Treating Chronic Venous Leg Ulcers
Official title: A Phase-3 Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of CureXcell® as an Adjunct to Good Ulcer Care Measures in Treating Chronic Venous Leg Ulcers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chronic Venous Leg Ulcers
Keywords: Chronic ulcers
Venous ulcers
Lead sponsor: Macrocure Ltd.
Sponsor class: INDUSTRY
First posted: 2014-05-05
Enrollment: 252
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: The primary objective is to evaluate the clinical benefit of CureXcell® as adjunct to Standard of Care in the treatment of Chronic Venous Leg Ulcers. CureXcell® is a cell based therapy, containing activated homologous white blood cells prepared from donated healthy whole blood. A total of 252 patients will be randomized to receive either CureXcell® or Placebo.


Eligibility criteria: Inclusion Criteria:

* Ankle Brachial Pressure Index (ABI) ≥ 0.80
* Venous insufficiency confirmed by duplex Doppler ultrasound
* Presence of a venous leg ulcer, unresponsive to Standard of Care treatment for at least 4 weeks and between ≥ 1 cm2 and ≤ 17.1 cm2 at screening; and between ≥ 1 cm2 and ≤ 12cm2 at the Baseline Visit

Exclusion Criteria:

* Target Ulcer has decreased \>30% in size from Screening to Baseline
* Documented history of osteomyelitis at the Target Ulcer location within 6 months preceding the Baseline Visit.
* Patients who are unable to tolerate multi-layer compression therapy.
* Ulcer, which in the opinion of the Investigator is suspicious for cancer.
* Any malignancy within the past 5 years, excluding successfully treated basal cell carcinoma or squamous cell carcinoma without evidence of metastases.
* History of radiation at the Target Ulcer site in previous 12 months prior to Baseline Visit.
* Patients with clinically significant claudication
* Current sepsis
* Patients with known history of significantly compromised immunity for any reason including radiation therapy, chemotherapy or HIV

Primary outcomes:
measure: Time to complete closure of Target Ulcer
timeFrame: up to 16 weeks
Secondary outcomes:
measure: Proportion of complete closure of Target Ulcer
timeFrame: up to 16 weeks
measure: Percentage change from baseline in Target Ulcer surface area
timeFrame: up to 12 weeks
measure: Proportion of Target Ulcer recurrence
timeFrame: up to 24 weeks
Other outcomes:
measure: Adverse Events
timeFrame: up to 24 weeks
Locations:
city: Mesa
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Carlsbad
country: United States
state: California
city: Castro Valley
country: United States
state: California
city: Fresno
country: United States
state: California
city: Laguna Hills
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Sylmar
country: United States
state: California
city: Hialeah
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: South Miami
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Oak Park
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Las Vegas
country: United States
state: Nevada
city: Emerson
country: United States
state: New Jersey
city: Summit
country: United States
state: New Jersey
city: Tom's River
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Willoughby
country: United States
state: Ohio
city: Wyomissing
country: United States
state: Pennsylvania
city: Dallas
country: United States
state: Texas
city: Lewisville
country: United States
state: Texas
city: McAllen
country: United States
state: Texas
Study officials:
affiliation: University of Miami
name: Robert Kirsner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Luke's-Roosevelt Hospital Center
name: John Lantis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Barry University Clinical Research
name: Robert Snyder, DPM
role: PRINCIPAL_INVESTIGATOR
References: