Evaluation of CureXcell® in Treating Chronic Venous Leg Ulcers

Status unconfirmed · Phase 3 · Has a placebo group

Conditions studied: Chronic Venous Leg Ulcers

In brief

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.

Key facts

Study ID

NCT02130310

Run by

Macrocure Ltd.

People needed

252

Starts

2014-05-01

Expected to finish

2016-06-01

Last updated by the study team

2015-09-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Mesa, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Carlsbad, California, United States
• Study site — Castro Valley, California, United States
• Study site — Fresno, California, United States
• Study site — Laguna Hills, California, United States
• Study site — Los Angeles, California, United States
• Study site — San Francisco, California, United States
• Study site — Sylmar, California, United States
• Study site — Hialeah, Florida, United States
• Study site — Miami, Florida, United States
• Study site — South Miami, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Oak Park, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Emerson, New Jersey, United States
• Study site — Summit, New Jersey, United States
• Study site — Toms River, New Jersey, United States
• Study site — New York, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Willoughby, Ohio, United States
• Study site — Wyomissing, Pennsylvania, United States

Full record on ClinicalTrials.gov

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