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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03518190
Enrollment
31
Registered
2018-05-08
Start date
2018-07-30
Completion date
2021-05-12
Last updated
2022-04-28

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

Conditions

Pressure Ulcer Not Visible

Brief summary

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

Detailed description

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/

Interventions

DEVICEInfrared spectroscopy (ODP)

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

Sponsors

Rambam Health Care Campus
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Early detection of pressure induced tissue damageTen minutesInfrared spectroscopy will indicate on a system-defined scale (yes/no) whether or not the subject has a pressure injury
Pressure injury probabilityTen minutesInfrared spectroscopy will calculate using accepted statistical tools the probability of the subject getting a pressure injury within the next few days

Countries

Israel

Outcome results

None listed

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