Status:
COMPLETED
Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Foot Ulcers.
Lead Sponsor:
Anterogen Co., Ltd.
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This is a phase III double-blind study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Diabetic Foot Ulcer, compared to placebo therapy.
Detailed Description
Experimental: ALLO-ASC-DFU, Placebo Comparator: Vehicle Sheet, Study type: Interventional, Study design: Randomized, Placebo-controlled, Double-blind, Parallel-group, Multi-center Study
Eligibility Criteria
Inclusion
- 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
- 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
- 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
Key Trial Info
Start Date :
June 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2020
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03370874
Start Date
June 27 2018
End Date
February 20 2020
Last Update
August 25 2023
Active Locations (1)
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1
Korea University Kuro Hospital
Seoul, South Korea