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| ID | Type | Description | Link |
|---|---|---|---|
| D20AC00002-13 | Other Grant/Funding Number | DARPA |
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| Name | Class |
|---|---|
| Defense Advanced Research Projects Agency | FED |
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The purpose of this research is to evaluate the ability of a Nitric Oxide (NO) Sensor to collect NO measurement data from an open wound. Previous research suggests that NO levels may indicate the stage of healing the wound is in. This study is being done to determine if the NO Sensor can measure how much NO is in a participant's wound. The researcher will place the NO Sensor into a participant's wound to collect NO measurements for 30-60 minutes. The participant will then have 2 follow-up appointments to see how the wound heals over time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NO Sensor | Experimental | NO sensor placed into wound bed |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NO Sensor | Device | NO sensor measuring wound characteristic data in wound bed |
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| Measure | Description | Time Frame |
|---|---|---|
| Participants meet all inclusion/exclusion criteria - a minimum of 5 participants have completed Inclusion/Exclusion in CRF-01 | up to 8 weeks | |
| All wound characteristics documented - a minimum of 5 wounds assessed by Bates-Jensen Wound Assessment Tool. And documented in CRF-03 | Day 0 | |
| NO Sensor application time > 30 minutes and < 60 minutes - a minimum of 5 wounds have NO sensor applied between 30-60 minutes and documented in CRF-04 | 60 minutes | |
| NO Sensor applied and removed according to study specific SOPs - a minimum of 5 wounds have NO Sensor applied and removed according to study specific SOPs and documented in CRF-04 | Day 0 | |
| Assessment of wound healing during participant follow-up activities - a minimum of 5 participants have follow up wound assessments according to visit schedule and documented in CRF-05 and CRF-06 | A follow up phone call within 72 hours and an in-person clinic visit within 2-8 weeks of NO Sensor application | up to 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Badylak, MD,DVM,PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Mercy | Pittsburgh | Pennsylvania | 15219 | United States |
no plan to raw share data
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proof of concept
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