Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Foot Ulcers.

Experimental: ALLO-ASC-DFU, Placebo Comparator: Vehicle Sheet, Study type: Interventional, Study design: Randomized, Placebo-controlled, Double-blind, Parallel-group, Multi-center Study

Inclusion criteria

• Subject is between 18 and 75 years of age.
• Subject is diagnosed with Type I or Type II diabetics and has diabetic foot ulcers for longer than 4 weeks at the screening visit.
• Foot ulcer size is between 1 cm2 and 15 cm2
• Ulcer graded I or II by Wagner grade, and extended to skin, tendon, and subcutaneous tissue.
• Free of necrotic debris at target ulcer
• Around ulcer area blood circulation should be secured to meet one of below criteria;

• Blood vessels around the ulcer detected by Doppler Test
• 0.7 < Ankle Brachial Index(ABI) < 1.3
• Transcutaneous Oxygen Pressure, TcPO2 higher than 30 mmHg
• Subject is able to give written informed consent prior to study start and to comply with the study requirements during study.

Exclusion criteria

• Non-diabetic pathophysiologic ulcer.
• The ulcer has increased or decreased in size by 30% or more during one week after the screening visit.
• Subjects requiring intravenous (IV) antibiotics to treat infection.
• Current evidence of infection including pus drainage from the wound site.
• Subject has a glycated hemoglobin A1c (HbA1c) level of > 15%
• Subject's blood sugar is > 450 mg/dl at postprandial.
• Subjects with severe renal failure that cannot be managed by renal dialysis.
• Subjects with severe hepatic deficiencies.
• Subject is Human Immunodeficiency Virus (HIV) positive.
• Subject who has allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue.
• Subject who is pregnant or breast-feeding.
• Subjects who are unwilling to use an "effective" method of contraception during the study.
• Subjects who have a clinically relevant history of alcohol or drugs abuse.
• Subjects who are not able to understand the objective of this study or to comply with the study requirements.
• Subjects who are considered to have a significant disease which can impact the study by investigator.
• Subjects who are considered not suitable for the study by investigator.
• Subjects who had had a history of surgery for malignant tumor within the last five years (except carcinoma in situ).
• Subjects who are currently or are enrolled in another clinical study within 60 days of screening.
• Subjects who have undergone wound treatments with growth factors, dermal substitutes, or other biological therapies within the last 30 days.
• Subjects who are receiving oral or parenteral corticosteroids, immunosuppressive, or cytotoxic agents with unstable dose prior to 4 weeks from screening.
• Subjects not comply with off-loading procedure