Pressure and Temperature Sensor for Therapeutic Compression Garments

Northwestern University26 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Healthy Adults Venous Leg Ulcer

Interventions

Pressure and Temperature SensorDEVICE

This device includes pressure and temperature sensor embedded within silicone and applied to the skin with a medical grade adhesive.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Northwestern University

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Pressure comparison with PicoPress

Percent variation for each subject for pressure

Time frame: 72 hours

Temperature with a comparator device (infrared camera)

Percent variation for each subject for temperature

Time frame: 72 hours

Secondary Outcomes

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.

Time frame: 72 hours

Participant survey

Survey regarding the comfort of the sensor

Time frame: 15 minutes

Data from ClinicalTrials.gov

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