Pressure and Temperature Sensor for Therapeutic Compression Garments

June 8, 2022 updated by: Shuai (Steve) Xu, Northwestern University

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

Pilot study of a soft, flexible pressure and temperature sensor

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 (Actual)

26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy adults without a history of medical or surgical problem. There will be no subject compensation.

Description

Inclusion Criteria:

  • Healthy adults over the age of 18 years old

Exclusion Criteria:

  • Subjects with history of medical or surgical problems

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy adults
Evaluate sensor performance on both lower limbs of healthy adult subjects for pressure sensing and skin temperature sensing.
Device: Pressure and Temperature Sensor
This device includes pressure and temperature sensor embedded within silicone and applied to the skin with a medical grade adhesive.
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.
Device: Pressure and Temperature Sensor
This device includes pressure and temperature sensor embedded within silicone and applied to the skin with a medical grade adhesive.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pressure comparison with PicoPress
Time Frame: 72 hours
Percent variation for each subject for pressure
72 hours
Temperature with a comparator device (infrared camera)
Time Frame: 72 hours
Percent variation for each subject for temperature
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
72 hours
Participant survey
Time Frame: 15 minutes
Survey regarding the comfort of the sensor
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

Wearifi, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2018

Primary Completion (Actual)

July 8, 2020

Study Completion (Actual)

August 10, 2021

Study Registration Dates

First Submitted

February 28, 2018

First Submitted That Met QC Criteria

March 8, 2018

First Posted (Actual)

March 12, 2018

Study Record Updates

Last Update Posted (Actual)

June 9, 2022

Last Update Submitted That Met QC Criteria

June 8, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 090717SX

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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