This is a phase II single-blinded study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Diabetic Foot Ulcer, compared to standard therapy.
ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating a Diabetic Foot Ulcer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
59
Application of ALLO-ASC-DFU sheet to diabetic foot ulcer
Standard therapy conducted for patients with diabetic foot ulcer
Korea University Guro Hospital
Guro-gu, Seoul, South Korea
Eulji General Hospital
Nowon-Gu, Seoul, South Korea
Severance Hospital
Seodaemun-Gu, Seoul, South Korea
Asan medical center
Songpa-Gu, Seoul, South Korea
Proportion of re-epithelialization
Time frame: During 8 weeks
Proportion of re-epithelialization
Time frame: During 12 weeks
Time to re-epithelialization
Time frame: During 12 weeks
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Follow up to 12 weeks
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