This is a phase 2 double-blind clinical study to evaluate the efficacy and Safety of ALLO-ASC-SHEET in subjects with Diabetic Wagner Grade II Foot Ulcers, compared to placebo therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
64
Hydrogel sheet containing Allogenic Mesenchymal Stem Cells
University of Southern California
Los Angeles, California, United States
RECRUITINGProportions of subjects who achieved complete wound closure.
Proportions of subjects who achieved complete wound closure during the 12 weeks.
Time frame: During 12 weeks
Time to initial complete wound closure between the 2 groups.
Measure the time to initial complete wound closure between the 2 groups.
Time frame: During 12 weeks
Changes in wound size compared to baseline between the 2 groups.
Wound size is measured by using eKare 3D Wound Measurement system(Mobile Devices).
Time frame: During 12 weeks
Proportions of subjects who achieved complete wound closure between the 2 groups by the classification of wound size.
Proportions of subjects who achieved complete wound closure by the classification of wound size, 1.5\~7 cm2 and 7.1\~15 cm2 between the 2 groups at every visit.
Time frame: During 12 weeks
Proportions of subjects who achieved complete wound closure between the 2 groups by the classification of location of diabetic foot ulcer.
Proportions of subjects who achieved complete wound closure by the classification of location of diabetic foot ulcer, plantar and dorsal between the 2 groups at every visit by post-hoc analysis.
Time frame: During 12 weeks
Durability of complete wound closure for the additional 24 weeks.
Durability of complete wound closure for the additional 24 weeks from the initial complete wound closure. Wound size is measured by using eKare 3D Wound Measurement system(Mobile Devices).
Time frame: During 36 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.