Pressure and Temperature Sensor for Therapeutic Compression Garments

Healthy Adults Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03461549
• Other study ID #: 090717SX
• Status: Completed
• Start date: February 27, 2018
• Est. completion date: August 10, 2021

Study information

• Verified date: June 2022
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Pilot study of a soft, flexible pressure and temperature sensor

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 10, 2021
• Est. primary completion date: July 8, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Healthy adults over the age of 18 years old

Exclusion Criteria:

• Subjects with history of medical or surgical problems

Related Conditions & MeSH terms

• Healthy Adults
• Leg Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

Intervention

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.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Wearifi, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pressure comparison with PicoPress	Percent variation for each subject for pressure	72 hours
Primary	Temperature with a comparator device (infrared camera)	Percent variation for each subject for temperature	72 hours
Secondary	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
Secondary	Participant survey	Survey regarding the comfort of the sensor	15 minutes