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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 Foot Ulcers, compared to placebo therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALLO-ASC-DFU | Experimental | Experimental: ALLO-ASC-DFU Hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells |
|
| Hydrogel SHEET(Vehicle control) | Placebo Comparator | Placebo Comparator: Vehicle Control Hydrogel sheet without allogenic adipose-derived mesenchymal stem cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALLO-ASC-DFU | Biological | Application of ALLO-ASC-DFU Sheet to diabetic foot ulcer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportions of subjects who achieved complete wound closure | Proportions of subjects who achieved complete wound closure | During 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to initial complete wound closure between the two groups | Time to initial complete wound closure between the two groups | During 12 weeks |
| Changes in wound size compared to baseline between the two groups |
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Inclusion Criteria:
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
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 | Affiliation | Role |
|---|---|---|
| David G. Armstrong, MD.Ph D. | University of Southern California | Principal Investigator |
| Alexander M. Reyzelman, DPM | Center for Clinical Research | Principal Investigator |
| Young Nathan, DPM | Martinsville Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90089 | 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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Double-Blind
| Hydrogel SHEET(Vehicle control) | Procedure | Application of Hydrogel SHEET to diabetic foot ulcer |
|
|
Wound size is measured by using eKare 3D Wound Measurement system(Mobile Devices)
| During 12 weeks |
| Proportions of subjects who achieved complete wound closure by the classification of location of diabetic foot ulcer, Plantar and the other location between the two groups | Proportions of subjects who achieved complete wound closure | During 12 weeks(at every visit during treatment period) |
| Durability of complete wound closure | Wound size is measured by using eKare 3D Wound Measurement system(Mobile Devices) | Follow up to 24 weeks from the initial complete wound closure. |
| 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 |