Intelligent Underwear (IU) in Paraplegics

NCT04008160 | Withdrawn

• 1 other identifier: 2013-04
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

perfusion; oxygenation; non invasive measurement

Outcome Measures

Primary Outcomes (1)

• change of pressure on skin

  measuring skin surface pressure with a pressure sensor in the underpants

  baseline and 10 minutes later

Secondary Outcomes (4)

• change in skin temperature

  baseline and 10 minutes later

• change in skin perfusion

  baseline and 10 minutes later

• change in skin humidity

  baseline and 10 minutes later

• change in skin oxygenation

  baseline and 10 minutes later

Study Arms (2)

healthy persons

Device: ProTex

individuals with paraplegia

Device: ProTex

Interventions

ProTex DEVICE

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

healthy persons; individuals with paraplegia

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

healthy volunteers and individuals with paraplegia

You may qualify if:

• men and women
• age: 18 - 50 years

You may not qualify if:

• Any sign of pressure ulcer or a history of pressure ulcer on the ischium
• Diabetes
• Acute infection or disease

Sponsors & Collaborators

• Swiss Paraplegic Research, Nottwil: lead
• University of Bern: collaborator

Study Sites (1)

Swiss Paraplegic Centre

Nottwil, Switzerland

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Pressure Ulcer

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 5, 2019
• Study Start: October 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)