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The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, randomized trial in which pressure ulcers will be treated using Aurix and standard care and compared 1:1 to patients receiving undefined Usual and Customary Care.
Pressure ulcers (PUs) are a common problem in all patient care settings, especially long-term acute care facilities and nursing homes. Aurix is a platelet-rich plasma gel used in the treatment of non-healing chronic wounds. The results of Aurix to date when used to treat PUs have been promising. The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, randomized trial in which pressure ulcers will be treated using Aurix and standard of care to determine time to heal at 16 weeks. Comparison will be made to patients receiving undefined Usual and Customary Care in a 1:1 manner.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aurix + UCC | Experimental | Subjects will be treated on average twice a week for the first 2 weeks, and then, once a week thereafter while under active treatment, but actual frequency of treatment will be determined by the treating physician. All subjects will receive Aurix treatment and usual and customary care, which can include advanced therapeutics. |
|
| Usual and Customary Care | No Intervention | Subjects will be treated on average twice a week for the first 2 weeks, and then, once a week thereafter while under active treatment, but actual frequency of treatment will be determined by the treating physician. All subjects will receive usual and customary care, which can include advanced therapeutics. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aurix | Device | Aurix is a platelet-rich plasma gel used in the treatment of non-healing wounds. It will be administered twice weekly for 2 weeks then weekly. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Heal | Compare complete wound healing at 16 weeks for all pressure ulcers treated with Aurix plus standard of care with patients randomized to usual and customary care. Complete wound closure is defined as skin re-epithelialization without drainage or dressing requirements confirmed at two consecutive study visits 2 weeks apart (FDA Guidance for Industry Chronic Cutaneous Ulcer and Burn Wounds - Developing Products for Treatment, 2006). | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of healed ulcers | Proportion of patients with completely healed pressure ulcers | 16 weeks |
| W-QOL (Quality of Life with Chronic Wounds) score | Change in mean W-QOL (Quality of Life with Chronic Wounds) score between baseline and 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stacy Gardner | Contact | 240-406-1816 | sgardner@nuot.com |
| Name | Affiliation | Role |
|---|---|---|
| Peter Clausen, PhD | Nuo Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Methodist Hospital Wound Care Center | Recruiting | Arcadia | California | 91007 | United States |
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| 16 weeks |
| Beverly Hospital Wound and Hyperbaric Center | Recruiting | Montebello | California | 90640 | United States |
|
| Kaweah Delta Rehabiliation Hospital | Recruiting | Visalia | California | 93277 | United States |
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| Bristol Hospital Wound Care Center | Recruiting | Bristol | Connecticut | 06410 | United States |
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| Piedmont | Recruiting | Atlanta | Georgia | 30309 | United States |
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| St. Luke's Wound and Hyperbaric Center | Recruiting | Meridian | Idaho | 86342 | United States |
|
| The Center for Wound Healing at FHN | Recruiting | Freeport | Illinois | 61032 | United States |
|
| Tufts Medical Center - Center for Wound Healing | Recruiting | Boston | Massachusetts | 02111 | United States |
|
| St Joseph Mercy Oakland Hospital Center for Wound Care and Hyperbaric Medicine | Recruiting | Pontiac | Michigan | 48341 | United States |
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| Catskill Regional Medical Center - Wound Healing Center | Recruiting | Harris | New York | 12742 | United States |
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| Orange Regional | Recruiting | Middletown | New York | 10940 | United States |
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| The Wound Center of Niagara | Recruiting | Niagara Falls | New York | 14301 | United States |
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| Onslow Memorial Hospital - Wound Care and Hyperbaric Center | Recruiting | Jacksonville | North Carolina | 28546 | United States |
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| The Center for Wound Healing Crozer Chester Medical Center | Recruiting | Chester | Pennsylvania | 19013 | United States |
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| Aria Health Bucks Wound Center | Terminated | Langhorne | Pennsylvania | 19047 | United States |
| Aria Health Frankford Wound Care Center | Terminated | Philadelphia | Pennsylvania | 19124 | United States |
| Memorial Hermann Memorial City | Recruiting | Houston | Texas | 77024 | United States |
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| Memorial Hermann South West | Recruiting | Houston | Texas | 77074 | United States |
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| Memorial Hermann South East | Recruiting | Houston | Texas | 77089 | United States |
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| Memorial Hermann Katy Rehab | Recruiting | Katy | Texas | 77450 | United States |
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| St. Mary's Wound and Hyperbaric Center | Recruiting | Huntington | West Virginia | 25702 | United States |
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| The Center for Wound Healing Cabell Huntington Hospital | Recruiting | Huntington | West Virginia | 25703 | United States |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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