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New record created in clinical trials due to company re-branding, and inability to list new name as the sponsor.
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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 venous leg ulcers (VLU)n will be treated using Aurix and compared to patients receiving undefined Usual and Customary Care (UCC)
Recurrence of ulcers in the leg is common; two-thirds of patients are likely to experience recurring ulcers after the first ulcer. While treatment of the underlying venous disease, depending on the mode of treatment, can lower the recurrence rate in many patients, it does not affect recurrence. Aurix is a platelet-rich plasma (PRP) gel used in the treatment of non-healing chronic wounds. The aim of this trial is to demonstrate the effectiveness, measured as complete wound healing, in a prospective, randomized trial in which venous leg ulcers will be treated using Aurix and standard of care and compared 1:1 to patients receiving undefined Usual and Customary Care (UCC).
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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. |
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| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to Heal | Primary endpoint is time to wound healing after 12 weeks com pared with case matched controls receiving standard of 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). | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of wounds healed | Comparison of proportion of wounds healed over 12 weeks | 12 weeks |
| Change in Quality of Life with Chronic Wounds (W-QOL) Score | Change in mean Quality of Life with Chronic Wounds (W-QOL) score between baseline and at 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Clausen, PhD | Nuo Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Luke's Intermountain Research | Boise | Idaho | 83702 | United States |
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| 12 weeks |