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

Completed · Phase 3 · Has a placebo group

Conditions studied: Lower Extremity Chronic Ulcers in Diabetics

In brief

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.

Key facts

Study ID

NCT01421966

Run by

Macrocure Ltd.

People needed

285

Starts

2011-08-01

Expected to finish

2015-10-01

Last updated by the study team

2015-12-07

Who can join

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

You may qualify if…

• Males or females at least 18 years of age with diabetes type 1 or type 2;
• Patients with HbA1c ≤ 12%;
• 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;
• 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);
• Ankle Brachial Index ≥ 0.65;

You may not qualify if…

• Patients with more than two ulcers on the same foot or more than a total of three chronic ulcers;
• Patients with ulcers primarily caused by venous insufficiency;
• Patients whose target ulcer has decreased > 25% in size from screening to baseline;
• Malignancy within the past 5 years excluding successfully treated basal cell carcinoma;
• Significantly compromised immunity for any reason including radiation therapy, chemotherapy or HIV;
• Current clinical osteomyelitis;
• Acute Charcot foot;
• Current sepsis;

Where it is running

• Study site — Glendale, Arizona, United States
• Study site — Mesa, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Fresno, California, United States
• Study site — San Francisco, California, United States
• Study site — Sylmar, California, United States
• Study site — Gulf Breeze, Florida, United States
• Study site — Hialeah, Florida, United States
• Study site — Miami, Florida, United States
• Study site — South Miami, Florida, United States
• Study site — Evans, Georgia, United States
• Study site — Arlington Heights, Illinois, United States
• Study site — Chicago, Illinois, United States
• Study site — Oak Park, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Wichita, Kansas, United States
• Study site — Boston, Massachusetts, United States
• Study site — Kansas City, Missouri, United States
• Study site — Toms River, New Jersey, United States
• Study site — Mineola, New York, United States
• Study site — New York, New York, United States
• Study site — Lima, Ohio, United States
• Study site — Aiken, South Carolina, United States
• Study site — Greenville, South Carolina, United States

Full record on ClinicalTrials.gov

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