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OpenTrials
Completed

NCT Number: NCT03461549

Pressure and Temperature Sensor for Therapeutic Compression Garments

Pilot study of a soft, flexible pressure and temperature sensor

Completed

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Key information

Conditions

Healthy Adults Cardiovascular Diseases Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Varicose Ulcer Varicose Veins Vascular Diseases Venous Leg Ulcer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy adults over the age of 18 years old

Exclusion criteria

  • Subjects with history of medical or surgical problems

Treatment and study plan

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.

Primary outcomes

  1. Pressure comparison with PicoPress

    Time frame: 72 hours

    Percent variation for each subject for pressure

  2. Temperature with a comparator device (infrared camera)

    Time frame: 72 hours

    Percent variation for each subject for temperature

Secondary outcomes

  1. Visual analogue scale of skin irritation

    Time frame: 72 hours

    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.

  2. Participant survey

    Time frame: 15 minutes

    Survey regarding the comfort of the sensor

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Wearifi, Inc.

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Mar 12, 2018
Registry last updated
Jun 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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