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CompletedNCT03518190Updated Apr 28, 2022

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

An interventional study of Infrared spectroscopy (ODP) in Pressure Ulcer Not Visible, sponsored by Rambam Health Care Campus. Completed at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-28.

Sponsored by Rambam Health Care Campus · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
31
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

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

Read the 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/

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Conditions studied

  • Pressure Ulcer Not Visible

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03

In context

Pressure Ulcer

518 studies on the registry are indexed under Pressure Ulcer; 117 are open to participants now.

This study's enrollment of 31 is below the median of 70 across 395 interventional studies indexed under Pressure Ulcer.

Browse Pressure Ulcer studies →

Lead sponsor

Rambam Health Care Campus is the lead sponsor of 456 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients with stage 2 pressure injury or higher
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    Suspected pressure injury

    Patients evaluated with high-risk for pressure injury

    Device: Infrared spectroscopy (ODP)

Interventions

  • DeviceInfrared spectroscopy (ODP)

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

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What researchers measure

Primary outcomes

  1. Early detection of pressure induced tissue damage

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

    Time frame: Ten minutes

  2. Pressure injury probability

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

    Time frame: Ten minutes

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Study locations

1 site
  • Rambam healrh care campus
    Haifa, Israel
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03518190
Lead sponsor
Rambam Health Care Campus
Responsible party
Yehuda Ullmann MD (Head of Plastic Surgery Department, Rambam Health Care Campus) — Principal investigator
First posted
May 8, 2018
Start date
Jul 30, 2018
Primary completion
May 12, 2021
Completion
May 12, 2021
Last update
Apr 28, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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