Pressure Ulcer Not VisibleNCT03518190
Early Detection of Pressure Induced Tissue Damage by Infrared Spectroscopy (ODP) Device
A study testing Infrared spectroscopy (ODP) in people with Pressure Ulcer Not Visible, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
The aim of this study is to demonstrate that infrared spectroscopy is able to detect pressure injuries at a very early stage Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcer Not Visible
- What is being tested?
- Infrared spectroscopy (ODP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteIsrael
- Study dates
- 30 Jul 2018to 12 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with stage 1 pressure injury
- Patients with high risk of developing pressure injury
Who cannot join
- Patients with stage 2 pressure injury or higher
Trial locations and contacts
1 site in 1 country.
About this study
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/
- Conditions
- Pressure Ulcer Not Visible
- Being tested
- Infrared spectroscopy (ODP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infrared spectroscopy (ODP)Device
Infrared spectroscopy device will be used to detect non-visible pressure injuries
| Study group | Role | What they receive |
|---|---|---|
| Suspected pressure injury | Experimental | Patients evaluated with high-risk for pressure injury Receives: Device: Infrared spectroscopy (ODP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Ten minutes
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
Measured: Ten minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start30 Jul 2018
- Primary completion12 May 2021
- Study completion12 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure Ulcer Not VisibleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yehuda Ullmann MD, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03518190
- Sponsor's protocol ID
- 0039-18-RMB
- Status last verified
- Apr 2022
- First submitted
- 25 Apr 2018
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Pressure Induced Tissue Damage by Infrared Spectroscopy (ODP) Device
- ClinicalTrials.gov ID
- NCT03518190
- Acronym / sponsor ID
- 0039-18-RMB
- Conditions
- Pressure Ulcer Not Visible
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 30 Jul 2018 (actual)
- Primary completion
- 12 May 2021 (actual)
- Study completion
- 12 May 2021 (actual)
- First posted
- 8 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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/
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspected pressure injury | Experimental | Device: Infrared spectroscopy (ODP)Patients evaluated with high-risk for pressure injury |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with stage 1 pressure injury
- Patients with high risk of developing pressure injury
Key exclusion criteria (1 listed)
- Patients with stage 2 pressure injury or higher
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infrared spectroscopy (ODP)Infrared spectroscopy device will be used to detect non-visible pressure injuries | Device | Suspected pressure injury |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infrared spectroscopy (ODP) in people with Pressure Ulcer Not Visible, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early detection of pressure induced tissue damage (time frame: Ten minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022.