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The study will evaluate changes in transcutaneous oxygen tension (tcPO2,), and the inferred change in local cutaneous blood flow, in healthy subjects wearing a control and a 100% Celliant® fiber upper torso garment.
Adequate blood supply is necessary for many physiologic processes. However, there are few valid, reproducible, non-invasive methods with which to assess it. One such measure is transcutaneous partial pressure of oxygen (tcPO2). This measurement is a non-invasive method of measuring oxygen tension at the skin surface; represents the amount of oxygen diffusing outward across the skin; and can be used as a surrogate for arterial perfusion. This method is reproducible with clinically acceptable intrasubject variability; is used for a variety of conditions, including peripheral vascular disease evaluation, predicting the outcome of patients requiring amputation and survival of skin grafts; and correlates well to angiography and increases in blood flow rates. However, tcPO2 is affected by many variables, including oxygen concentration in inspired air, lung function and hemoglobin saturation, as well as local factors, such as skin thickness, sympathetic tone, the presence of inflammation, capillary formation and skin oxygen consumption.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Active Comparator | Subject wearing Celliant garment |
|
| Control | Placebo Comparator | Subject wearing non-celliant control garment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celliant | Device | 100% Celliant garment |
| |
| Control |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in transcutaneous oxygen tension (tcPO2) | comparison of individual measurements taken at these time points | 0,30,60,90 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in local skin temperature by infrared imaging | comparison of individual measurements taken at these time points | 0,30,60,90 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ian L Gordon, M.D. | University of California Medical Center Wound Clinic | Principal Investigator |
| Kristopher Washington, B.S. | Hologenix, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hologenix, LLC | Santa Monica | California | 90403 | United States |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Informed Consent Form | View IPD |
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| Device |
Control Garment |
|
| Clinical Investigation plan | View IPD |
| Clinical Study Report | View IPD |