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| Name | Class |
|---|---|
| Imbed Biosciences | INDUSTRY |
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The purpose of this pilot study is to assess the efficacy of Microlyte Ag wound dressing when used in complex skin wounds. Microlyte Ag is a class-II medical device cleared by the FDA for prescription and over the counter use in humans. Primary clinical end point of study is percentage change in wound size from initiation of Microlyte Ag treatment through 90 days or until wound closure. Patient population comprises patients referred to Mission's Wound Healing and Hyperbaric Center for management of their wounds. Targeted enrollment is 100 subjects distributed into 4 study cohorts corresponding to the type of wound treated: venous stasis ulcer (20 patients); diabetic foot ulcer [DFU] (20 patients); pressure ulcer (20 patients); wounds of various other etiologies (40 patients).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venous Stasis Ulcer | Active Comparator | Venous Stasis Ulcer |
|
| Pressure Ulcers | Active Comparator | Pressure Ulcers |
|
| Diabetic Foot Ulcers | Active Comparator | Diabetic Foot Ulcers |
|
| Wounds from a variety of etiologies | Active Comparator | Wounds from a variety of etiologies |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wound Healing | Device | Microlyte Ag is a class-II medical device cleared by the FDA for prescription and over the counter use in humans with skin wounds. |
|
| Measure | Description | Time Frame |
|---|---|---|
| percentage change in wound size from initiation of Microlyte Ag treatment through 90 days or until wound closure. | Wound Healing | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lorinda Baker | Contact | 828-257-4744 | lorinda.baker@hcahealthcare.com | |
| Ashley Boone, BS | Contact | 828-213-3961 | Ashley.boone@hcahealthcare.com |
| Name | Affiliation | Role |
|---|---|---|
| William Shillinglaw, DO | Mission Health System | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mission Health System | Recruiting | Asheville | North Carolina | 28801 | United States |
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