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Intelligent Underwear (IU) in Paraplegics

NCT04008160 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2025-05-28

No results posted yet for this study

Summary

Pressure injuries are a major problem in patients with no or limited mobility and sensation such as paraplegics. Changes in skin physiology like changes in skin perfusion, oxygenation and humidity may explain and help to detect pressure injury development earlier. Thus, these parameters may be used for continuous monitoring of skin health. So far, there is no measuring technology available which would allow to measure continuously and quantitatively the physiological parameters, which are essential in the development of pressure injuries, over a long period of time in the clinical setting.

The goal of this pilot study is to test whether this wearable technology can be used for measurements of skin parameter and whether temperature, pressure, humidity, perfusion, and oxygenation can be measured safely and accurately.

10 healthy individuals and 10 individuals with spinal cord will be enrolled for measurements with this newly developed device over the ischium for 30 minutes. The reproducibility of the measurements will be investigated.

Conditions

  • Skin Physiology
  • Spinal Cord Injuries
  • Pressure Injury

Interventions

DEVICE

ProTex

Non invasive measurement of pressure, temperature, humidity, perfusion, and oxygenation

Sponsors & Collaborators

  • University of Bern

    collaborator OTHER

  • Swiss Paraplegic Research, Nottwil

    lead NETWORK

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2023-06-01
Completion
2023-06-01

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04008160 on ClinicalTrials.gov