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This is a phase 2 double-blind clinical study to evaluate the efficacy and Safety of ALLO-ASC-SHEET in subjects with Diabetic Wagner Grade II Foot Ulcers, compared to placebo therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALLO-ASC-SHEET | Experimental | ALLO-ASC-SHEET Hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells |
|
| Hydrogel SHEET(Vehicle control) | Placebo Comparator | Vehicle Control Hydrogel sheet without allogenic adipose-derived mesenchymal stem cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALLO-ASC-SHEET | Biological | Hydrogel sheet containing Allogenic Mesenchymal Stem Cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportions of subjects who achieved complete wound closure. | Proportions of subjects who achieved complete wound closure during the 12 weeks. | During 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to initial complete wound closure between the 2 groups. | Measure the time to initial complete wound closure between the 2 groups. | During 12 weeks |
| Changes in wound size compared to baseline between the 2 groups. |
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Inclusion Criteria:
Male or female between 18 and 80 years of age.
Diagnosed with Type I or Type II diabetes and has Wagner Grade II diabetic foot ulcers for longer than 4 weeks at the time of screening.
Foot ulcer located in the plantar or dorsal, with ulcer size between1.5 cm2 and 15 cm2.
Ulcer, Graded II by Wagner grade, and extended to muscle periosteum, muscle, tendon, or joint capsule, but not to bone.
Ulcer is free of necrotic debris,exhibits no signs of clinical infection.
Ulcer area blood circulation meets 1 of the following criteria:
A. Blood vessels around the ulcer detected by Doppler Test to have biphasic or triphasic flow B. Range of Ankle Brachial Index(ABI) is>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 Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yun Jung Choi, PM | Contact | 82 10 9199 0164 | yunjungchoi@anterogen.com | |
| Jessi Choi, PM | Contact | 82 10 9199 0164 |
| Name | Affiliation | Role |
|---|---|---|
| Yun Jung Choi, PM | Anterogen Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Recruiting | Los Angeles | California | 90033 | United States |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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Wound size is measured by using eKare 3D Wound Measurement system(Mobile Devices).
| During 12 weeks |
| Proportions of subjects who achieved complete wound closure between the 2 groups by the classification of wound size. | Proportions of subjects who achieved complete wound closure by the classification of wound size, 1.5~7 cm2 and 7.1~15 cm2 between the 2 groups at every visit. | During 12 weeks |
| Proportions of subjects who achieved complete wound closure between the 2 groups by the classification of location of diabetic foot ulcer. | Proportions of subjects who achieved complete wound closure by the classification of location of diabetic foot ulcer, plantar and dorsal between the 2 groups at every visit by post-hoc analysis. | During 12 weeks |
| Durability of complete wound closure for the additional 24 weeks. | Durability of complete wound closure for the additional 24 weeks from the initial complete wound closure. Wound size is measured by using eKare 3D Wound Measurement system(Mobile Devices). | During 36 weeks |
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |