Safety of ALLO-ASC-DFU in the Patients With Diabetic Foot Ulcers

Inclusion criteria

• Subject is between 18 and 80 years of age.
• Subject is diagnosed with Type I or Type II diabetes.
• Subjects who have a wound defined as diabetic foot ulcer presence for more than 4 weeks, but not present for more than 54 weeks at the screening visit.
• Foot ulcer located below the malleoli on plantar or dorsal surface of the foot and ulcer size is between 1 cm^2 and 25 cm^2.
• Ulcer extends into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone, or joint capsule.
• Ulcer is free of necrotic debris, exhibits no signs of clinical infection, and appears to be made of primarily vascularized tissue.
• 0.7 < Ankle Brachial Index (ABI) < 1.3.
• Subject is able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion criteria

• Ulcer is of non-diabetic pathophysiology.
• Gangrene is present on any part of the affected foot.
• Ulcer is over an active Charcot deformity.
• The ulcer has increased or decreased in size by 30% or more during one week after the screening visit.
• The longest dimension of the Index Ulcer exceeds 5 cm at the screening visit.
• Subject is Human Immunodeficiency Virus (HIV) positive.
• Subjects with severe hepatic deficiencies.
• Subjects with a glycated hemoglobin A1c (HbA1c) level of > 12%.
• Subject who are allergic or have a hypersensitive reaction to bovine-derived proteins or fibrin glue.
• Subjects requiring intravenous (IV) antibiotics to treat the index wound infection.
• Subjects who are currently receiving dialysis.
• Subjects who are pregnant or breast-feeding.
• Subjects who are unwilling to use an "effective" method of contraception during the study.
• Current evidence of osteomyelitis, cellulitis, or other evidence of infection including pus drainage from the wound site.
• Subjects who have a clinically relevant history of alcohol or drugs abuse.
• Subject's blood sugar is > 450 mg/dL at postprandial.
• 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 the investigator.
• Subjects who are considered not suitable for the study by the investigator.
• Subjects who have a history of surgery for malignant tumor within the last five years (except carcinoma site).
• Subjects who are currently or were 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.