This is a phase III double-blind study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Diabetic Wagner grade 2 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
104
Application of ALLO-ASC-DFU sheet to Diabetic Wagner grade 2 Foot Ulcer
Application of Vehicle sheet to Diabetic Wagner grade 2 Foot Ulcer
Bucheon ST. Mary's Hospital
Gyeonggi-do, Bucheon, South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, Seongnam-si, South Korea
Asan Medical Center
Seoul, Seoul, South Korea
Borame Medical Center
Seoul, Seoul, South Korea
Proportions of subjects who achieved complete wound closure
Time frame: During 12 weeks
Time taken to complete wound closure
Time frame: During 12 weeks
Proportions of subjects who achieved complete wound closure at every visit
Time frame: During 12 weeks
Change rates in wound size and depth compared to baseline groups
Time frame: During 12 weeks
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Korea University Guro Hospital
Seoul, Seoul, South Korea