Pressure and Temperature Sensor for Therapeutic Compression Garments

Study Overview
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Brief Summary
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Pilot study of a soft, flexible pressure and temperature sensor

Detailed Description
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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.

Official Title
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Open-label Preliminary Assessment of a Thin Flexible Pressure and Temperature Sensor for Therapeutic Compression Garments Using a Cohort of Healthy Adults Phase 2: Point-of-Care Wearable Pressure/Temp Sensor System for Therapeutic Compression Garments in Venous Leg Ulcers

Conditions
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Healthy Adults, Venous Leg Ulcer

Intervention / Treatment
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* Device: Pressure and Temperature Sensor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults over the age of 18 years old Exclusion Criteria: Subjects with history of medical or surgical problems

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy adults<br>Evaluate sensor performance on both lower limbs of healthy adult subjects for pressure sensing and skin temperature sensing. | Device: Pressure and Temperature Sensor<br>* This device includes pressure and temperature sensor embedded within silicone and applied to the skin with a medical grade adhesive.<br>|
| Venous Leg Ulcer Adults<br>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. | Device: Pressure and Temperature Sensor<br>* This device includes pressure and temperature sensor embedded within silicone and applied to the skin with a medical grade adhesive.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Survey regarding the comfort of the sensor | 15 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pressure sensor, temperature sensor, wearables