This is a phase III double-blind study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Diabetic Foot Ulcer, compared to placebo therapy.
Experimental: ALLO-ASC-DFU, Placebo Comparator: Vehicle Sheet, Study type: Interventional, Study design: Randomized, Placebo-controlled, Double-blind, Parallel-group, Multi-center Study
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
150
Application of ALLO-ASC-DFU sheet to diabetic foot ulcer
Application of Vehicle sheet to diabetic foot ulcer
Korea University Kuro Hospital
Seoul, South Korea
Proportions of subjects who achieved complete wound closure
Time frame: During 12 weeks
Time taken to complete wound closure between the two groups
Time frame: During 12 weeks
Proportions of subjects who achieved complete wound closure
Time frame: Follow up to 12 weeks
Proportions of subjects who achieved complete wound closure by the classification of Wagner Grade between the two groups
Time frame: Follow up to 12 weeks
Change rates in wound size and depth compared to baseline between the two groups
cm\^2
Time frame: During 12 weeks
Proportions of subjects who achieved complete wound closure at every visit by the classification of ulcer locations
Time frame: Follow up to 12 weeks
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