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This research project is testing a product called AmnioClear™ which is an amniotic membrane graft processed for Liventa Bioscience formerly AFCell Medical. AmnioClear™ allograft human amniotic membrane is regulated solely under section 361 of the Public Health Service Act.
The purpose of the study is to see if this treatment works to accelerate the healing time of chronic wounds.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AmnioClear™ | Active Comparator | AmnioClear™ Human Allograft Amniotic Membrane |
|
| Standard of Care | No Intervention | Standard moist wound dressing (saline wet-to-moist or a hydrogel dressing) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AmnioClear™ Human Allograft Amniotic Membrane | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Wound Size | Clinical assessment of wound healing in terms of the reduction in size and shape of the wound over time. | 12 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 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 |
| 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 |
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