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| Name | Class |
|---|---|
| Wearifi, Inc. | UNKNOWN |
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Pilot study of a soft, flexible pressure and temperature sensor
Assessment of safety, and preliminary accuracy of a pressure and temperature sensor adherent to the skin. The pressure sensor includes a piezoresistive fabric coupled to a near-field communication chip with a built-in temperature sensor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy adults | Evaluate sensor performance on both lower limbs of healthy adult subjects for pressure sensing and skin temperature sensing. |
| |
| Venous Leg Ulcer Adults | Evaluate sensor performance on both lower limbs of adult subjects with an active venous leg ulcer or history of a venous leg ulcer for pressure sensing and skin temperature sensing. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pressure and Temperature Sensor | Device | This device includes pressure and temperature sensor embedded within silicone and applied to the skin with a medical grade adhesive. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pressure comparison with PicoPress | Percent variation for each subject for pressure | 72 hours |
| Temperature with a comparator device (infrared camera) | Percent variation for each subject for temperature | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Visual analogue scale of skin irritation | A minimum score is 0 and a maximum score is 100 with a range of 0-100. A score of 0 is defined as no visible clinical appreciation. A score of 100 is defined as severe skin irritation. Higher values indicate worse outcome. There are no subscales. | 72 hours |
| Participant survey |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy adults without a history of medical or surgical problem. There will be no subject compensation.
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| Name | Affiliation | Role |
|---|---|---|
| Shuai Xu | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
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| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
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Survey regarding the comfort of the sensor |
| 15 minutes |
| D012883 |
| Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |