Status:
COMPLETED
Clinical Study of ALLO-ASC-SHEET in Subjects with Diabetic Foot Ulcers
Lead Sponsor:
Anterogen Co., Ltd.
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This is a phase 2 double-blind clinical study to evaluate the efficacy and Safety of ALLO-ASC-SHEET in subjects with Diabetic Foot Ulcers, compared to placebo therapy.
Detailed Description
1. Active Group: ALLO-ASC-SHEET 2. Control Group: Hydrogel SHEET (vehicle control) 3. Study Type: Interventional 4. Study Design: Randomized, Comparator-controlled, Double-blind, multi-center study.
Eligibility Criteria
Inclusion
- Male or female subjects between 18 and 80 years of age.
- Diagnosed with Type I or Type II diabetics and has diabetic foot ulcers for longer than 4 weeks at the screening visit.
- Foot ulcer located in the instep, border or sole of the foot, with ulcer size between 1 cm2 and 15 cm2.
- Ulcer graded I by Wagner grade, and extended to skin, subcutaneous tissue, but without exposure of muscle, tendon, bone or joint capsule.
- Ulcer is free of necrotic debris, exhibits no signs of clinical infection.
- Ulcer area blood circulation meets one of the following criteria
- A. Blood vessels around the ulcer detected by Doppler Test
- B. range of Ankle Brachial Index(ABI) was \> 0.7 to \< 1.3
- C. Transcutaneous oxygen pressure, (TcPO2) \> 30 mmHg.
- Is able to give written informed consent prior to study start and to comply with the study requirements.
Exclusion
- Ulcer is of non-diabetic pathophysiology.
- The ulcer has increased or decreased in size by ≥ 30% during the week after the Screening Visit.
- Is Human Immunodeficiency Virus (HIV) positive?
- Have severe hepatic deficiencies.
- Have a glycated hemoglobin A1c (HbA1c) level of \> 10%.
- Have allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue.
- Require intravenous (IV) antibiotics to treat the target wound infection.
- Have severe renal failure including subject on renal dialysis.
- Pregnant or breast-feeding.
- Is unwilling to use an "effective" method of contraception during the study.
- Have evidence of current infection including pus drainage from the wound site.
- Have a clinically relevant history of alcohol or drugs abuse.
- Have postprandial blood sugar \> 350 mg/dl.
- Is not able to understand the objective of this study or to comply with the study requirements.
- Is considered by the investigator to have a significant disease which might have impacted the study.
- Is considered not suitable for the study by investigator.
- Have a history of malignancy within the last five years (except basal cell carcinoam 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, immunosuppressive, or cytotoxic agents with unstable dose prior to 4 weeks from screening.
- Cannot maintain off-loading process
- Panel reactive antibody (PRA) levels ≥ 20%
Key Trial Info
Start Date :
January 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 23 2023
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT03754465
Start Date
January 2 2019
End Date
October 23 2023
Last Update
January 23 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Southern California
Los Angeles, California, United States, 90089