Wounds Clinical Trial
Official title:
A Multi-Center Post- Marketing Study to Define Procedures for the Use of CureXcellTM in a Community Setting for the Treatment of Wounds
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).
n/a
Observational Model: Cohort, Time Perspective: Prospective
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