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Completed

NCT Number: NCT03518190

Early Detection of Pressure Induced Tissue Damage by Infrared Spectroscopy (ODP) Device

The aim of this study is to demonstrate that infrared spectroscopy is able to detect pressure injuries at a very early stage

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Key information

Conditions

Pressure Ulcer Not Visible

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rambam healrh care campus

Haifa, Israel

About this study

During pressure injuries formation early sub dermal bio signal appear. By applying infrared spectroscopy at a suspicions injury site on the human body and obtaining a reflected infrared light infrared allows to determine early formation of a pressure injury/

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with stage 1 pressure injury
  • Patients with high risk of developing pressure injury

Exclusion criteria

  • Patients with stage 2 pressure injury or higher

Treatment and study plan

Infrared spectroscopy (ODP)

Device

Infrared spectroscopy device will be used to detect non-visible pressure injuries

Primary outcomes

  1. Early detection of pressure induced tissue damage

    Time frame: Ten minutes

    Infrared spectroscopy will indicate on a system-defined scale (yes/no) whether or not the subject has a pressure injury

  2. Pressure injury probability

    Time frame: Ten minutes

    Infrared spectroscopy will calculate using accepted statistical tools the probability of the subject getting a pressure injury within the next few days

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
May 8, 2018
Registry last updated
Apr 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.