After confirming eligibility, a single subject with four selected target lesions will receive both ALLO-ASC-SHEET and Vehicle control, three target lesions for ALLO-ASC-SHEET and the other target for Vehicle control, and which lesion to apply which IP treatment will be determined randomly at the time of enrollment using pre-designed block randomization scheme.
Primary efficacy endpoint will be assessed during and after 12th IP applications.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
6
Weekly administration
Weekly administration
University of Miami Dermatology Clinical Trials Unit
Miami, Florida, United States
RECRUITINGIncidence of Treatment-Emergent Adverse Events
Incidence, severity, relationship of adverse event
Time frame: First application to week 37
Proportion of complete wound closure
Proportion of subject with target skin ulcer area meeting the definition of wound closure during and at the completion of 12 weeks treatment
Time frame: First application to week 17
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