Pressure and Temperature Sensor for Therapeutic Compression Garments

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03461549

Enrollment

Registered

2018-03-12

Start date

2018-02-27

Completion date

2021-08-10

Last updated

2022-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Adults, Venous Leg Ulcer

Keywords

pressure sensor, temperature sensor, wearables

Brief summary

Pilot study of a soft, flexible pressure and temperature sensor

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.

Interventions

DEVICEPressure and Temperature Sensor

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Healthy adults over the age of 18 years old

Exclusion criteria

* Subjects with history of medical or surgical problems

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Visual analogue scale of skin irritation	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.
Participant survey	15 minutes	Survey regarding the comfort of the sensor

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026