Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Wagner Grade 2 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 19 and 75 years of age.
• Subject is diagnosed with Type I or Type II diabetics.
• Diabetic foot ulcer has been more than 4 weeks but less than 52 weeks at the screening visit.
• Ulcer located in the foot and ulcer size is between 1.5~15 cm2.
• Ulcer graded 2 by Wagner grade.
• Foot ulcer extended to ligament, tendon, joint capsule, fascia, muscle and periosteum.
• Ulcer is free of necrotic debris.
• Ulcer area blood circulation meets one of the following criteria;

• Blood vessels around the ulcer detected by Doppler Test
• Range of Ankle Brachial Index (ABI) is > 0.7 to < 1.3
• Transcutaneous Oxygen Pressure (TcPO2) > 30mmHg or Toe Blood Pressure (TBP) > 40mmHg.
• Skin Perfusion Pressure (SPP) > 30mmHg
• Subject is able to give written informed consent prior to study start and willing to comply with the study requirements.

Exclusion criteria

• Ulcer is of non-diabetic pathophysiology.
• There is gangrene in any part of the target foot ulcer.
• The longest dimension of the target foot ulcer exceeds 15 cm at the enrollment visit.
• Other wounds within 2cm of the target foot ulcer.
• The ulcer has increased or decreased in size by ≥ 30% during two weeks after the screening visit.
• Patient requiring intravenous (IV) antibiotics to treat foot wound infection at the screening and enrollment visit.
• Current evidence of active charcot on the study foot, osteomyelitis, cellulitis, or evidence of other infection including fever or purulent drainage from wound site.
• Patient with skin lesion confirmed by biopsy (when Investigator deems suspicious) and then judged by Investigator to be an etiology other than diabetic foot ulcer.
• An active malignant tumor(malignant melanoma, squamous cell carcinoma, basal cell carcinoma) on the body or skin.
• Have a glycated hemoglobin A1c (HbA1c) level of > 14%
• Have random blood sugar > 450mg/dL
• Have severe renal failure with creatinine > 3.0mg/dL.
• Have severe hepatic deficiencies

• Total bilirubin ≥ 1.5×upper normal limit(UNL)
• AST, ALT ≥ 2.0×UNL
• Serum albumin < 2.0mg/dL
• Is Human Immunodeficiency Virus (HIV) positive
• Have a known history of allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue
• Pregnant or breast-feeding.
• Is unwilling to use an acceptable method of birth control during the whole study.
• Have a clinically relevant history of alcohol or drugs abuse at the screening visit.
• Is not able to understand the objective of the study or to comply with the study requirements
• Is considered by the Investigator to have a significant disease which might impact the study
• Is considered not suitable for the study by Investigator
• Have a history of malignancy within the last 5 years (except carcinoma in situ)
• Is currently or were enrolled in another clinical study within 60 days of screening
• Have undergone wound treatments with growth factors, dermal substitutes, or other biological therapies within the last 30 days.
• Is receiving oral or parenteral corticosteroids, any immunosuppressive, or cytotoxic agents with unstable dose within the last 30 days
• Cannot maintain off-loading process and device.