The primary objective of the study is to define procedures for the use of CureXcellTM in the community through Clalit Health Services. Secondary objective is to evaluate the blinding method in a subgroup of patients, which will be used in a future study named: a multinational, multi-center, randomized, double blind, placebo controlled study for the evaluation of the tolerability, safety and efficacy of CureXcell™ therapy plus adequate ulcer treatment, in diabetic patients with ulcers in the lower extremities. Adults with chronic ulcers; pressure ulcers, venous ulcers, diabetic foot ulcers or post operative ulcer will be recruited to the study. Patients that have been recruited for the study will be treated as required for their medical condition. As required, cultures will be taken, IV or PO antibiotics will be given and debridement will be carried out. Patients will be referred to catheterization, revascularization, or amputation as required and the decision to do so will not be affected in any way by the study. CureXcellTM will be used as adjunct treatment to good ulcer care (GUC).
Study Type
OBSERVATIONAL
Enrollment
131
The CUREXCELL™ dosage form consists of an activated cell suspension that has been isolated, activated and purified from the peripheral blood of healthy allogeneic donors, by hypo-osmotic shock, using the MacroCure custom closed bag system.The cell suspension is superficially injected throughout the wound bed ( 0.1ml per 1 cm2 of wound bed).
Omer Clalit Clinic
Afula, Israel
Sold Clalit Clinic
Beersheba, Israel
Hamoshava Diabetic Wound Clinic
Jerusalem, Israel
Ramat Eshcol Wound Clinic
Jerusalem, Israel
Zvulun Wound Clinic
Kiryat Bialik, Israel
Hasharon Medical Center
Petah Tikva, Israel
Zamenhoff Wound Clinic
Tel Aviv, Israel
Proportion of patients with complete wound closure
Time frame: Week 24
Median time to complete wound closure
Time frame: End of study
Change in wound area between Baseline and Last Observation
Time frame: End of study
Rate of wound infections, cellulitis, and osteomyelitis
Time frame: End of study
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