This is a phase 2 double-blind clinical study to evaluate the efficacy and Safety of ALLO-ASC-SHEET in subjects with Diabetic Foot Ulcers, compared to placebo therapy.
1. Active Group: ALLO-ASC-SHEET 2. Control Group: Hydrogel SHEET (vehicle control) 3. Study Type: Interventional 4. Study Design: Randomized, Comparator-controlled, Double-blind, multi-center study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
66
Application of ALLO-ASC-DFU Sheet to diabetic foot ulcer
Application of Hydrogel SHEET to diabetic foot ulcer
University of Southern California
Los Angeles, California, United States
Proportions of subjects who achieved complete wound closure
Proportions of subjects who achieved complete wound closure
Time frame: During 12 weeks
Time to initial complete wound closure between the two groups
Time to initial complete wound closure between the two groups
Time frame: During 12 weeks
Changes in wound size compared to baseline between the two 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 by the classification of location of diabetic foot ulcer, Plantar and the other location between the two groups
Proportions of subjects who achieved complete wound closure
Time frame: During 12 weeks(at every visit during treatment period)
Durability of complete wound closure
Wound size is measured by using eKare 3D Wound Measurement system(Mobile Devices)
Time frame: Follow up to 24 weeks from the initial complete wound closure.
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