MicrocirculationMRT02NCT03357523
Evaluation of Peripheral Microcirculation Hemodynamics Following Various Changes Based on Noninvasive Thermography
A study testing Omnilux new-U (Red LED), Omnilux new-U (Near infrared LED) and RESPeRATE in people with Microcirculation, run by Afeka, The Tel-Aviv Academic College of Engineering at 1 site in Israel.
Trial summary
The objective of the current study is to investigate the hemodynamic changes in the peripheral microcirculation system as a response to various changes, using noninvasive thermography and laser doppler Read more about this study
- Who is it for?
- Ages 23 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Microcirculation
- What is being tested?
- Omnilux new-U (Red LED), Omnilux new-U (Near infrared LED) and RESPeRATE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Nov 2017to 31 Dec 2019
- 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 23 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females, between 23 and 45 years of age.
- Willing to sign informed consent
Who cannot join
- Currently smoking
- Any abnormal skin condition in the area of light irradiation.
- Pregnant having given birth less than 3 months ago, and/or breastfeeding.
- Having a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen.
- Having any illness that might affect the vasculature, such as diabetes (type I or II)
- Suffering from significant concurrent illness, such as cardiac disorders or pertinent neurological disorders.
- As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Peripheral Microcirculation Hemodynamics Following Various Changes Based on Noninvasive Thermography: A Prospective, Randomized, Controlled Trial
The objective of the current study is to investigate the hemodynamic changes in the peripheral microcirculation system as a response to various changes, using noninvasive thermography and laser doppler
Read the detailed description
This study includes a single session per subject. Microvascular and systemic variables will be monitored in response to a number of non-invasive interventions/device that are approved for clinical use and known to elicit microvascular responses. These interventions are applied consecutively, include breathing at different rates, low power visible light in the red-to-near-infrared range, increase in local temperature, and changes in the arm position.
- Conditions
- Microcirculation
- Being tested
- Omnilux new-U (Red LED), Omnilux new-U (Near infrared LED), RESPeRATE, Heating bag
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omnilux new-U (Red LED)Device
The left wrist (including area of radial artery) will be illuminated with the Omnilux new-U (Red LED) light source, while the right wrist will not be illuminated
Omnilux new-U (Near infrared LED)Device
The left wrist (including area of radial artery) will be illuminated with the Omnilux new-U (Near infrared LED) light source, while the right wrist will not be illuminated
RESPeRATEDevice
The subjects will be guided by a digital metronome to breath at 15, 10, and 6 breaths/min for 2 minutes each using the metronome function of the device RESPeRATE (InterCure, Israel) that guides breathing using musical tones played at selectable rhythm
Heating bagDevice
Applying a standard 10X13 [cm] heating bag on the surface of the hand at 43-45 degree Celsius for 10 seconds
| Study group | Role | What they receive |
|---|---|---|
| Red LED | Experimental | Light emitting diodes, 633 nm, 70 mW/cm2, Omnilux new-U (Red LED) (Photomedex, Horsham, PA, USA); RESPeRATE; Heating bag Receives: Device: Omnilux new-U (Red LED); Device: RESPeRATE; Device: Heating bag |
| Near Infrared LED | Active comparator | Light emitting diodes, 830 nm, 55 mW/ cm2, Omnilux new-U (Near infrared LED) (Photomedex, Horsham, PA, USA); RESPeRATE metronome; Heating bag Receives: Device: Omnilux new-U (Near infrared LED); Device: RESPeRATE; Device: Heating bag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Capillary blood flow
Capillary blood flow (red blood cell velocity or flux in 'perfusion units') as measured by laser doppler (Biopac™ System, Inc, USA). This is a continuous measurement (at least 10 Hz sampling rate) from baseline to end of experiment.
Measured: Up to 1 hour
Secondary outcomes (2)
Temperature distribution over hands measured by thermography
Thermographic images will be photographed with a FLIR camera and temperature distribution will be analysed. Photos will be taken every minute from baseline to end of experiment.
Measured: Up to 1 hour
Tissue oxygenation (tcPO2)
Tissue oxygenation (tcPO2) measured by electrodes mounted on both hands (Perimed™ system, Sweden). This is a continuous measurement (at least 10 Hz sampling rate) from baseline to end of experiment.
Measured: Up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study start1 Nov 2017
- Primary completion1 Jun 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MicrocirculationStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afeka, The Tel-Aviv Academic College of Engineering
- Sponsor type
- University, hospital or other
- Collaborators
- Hebrew University of Jerusalem
- Responsible party
- Sponsor
- Investigators
- Zehava Blechman, PhD, Principal investigator, Afeka Tel Aviv Academic College of Engineering
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03357523
- Sponsor's protocol ID
- 05.04.2017-1-AFK
- Acronym
- MRT02
- Status last verified
- Nov 2021
- First submitted
- 20 Nov 2017
- Last updated
- 10 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gavish L, Hoffer O, Rabin N, Halak M, Shkilevich S, Shayovitz Y, Weizman G, Haim O, Gavish B, Gertz SD, Ovadia-Blechman Z. Microcirculatory Response to Photobiomodulation-Why Some Respond and Others Do Not: A Randomized Controlled Study. Lasers Surg Med. 2020 Nov;52(9):863-872. doi: 10.1002/lsm.23225. Epub 2020 Feb 17.
PubMed 32064652
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Peripheral Microcirculation Hemodynamics Following Various Changes Based on Noninvasive Thermography: A Prospective, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT03357523
- Acronym / sponsor ID
- MRT02 / 05.04.2017-1-AFK
- Conditions
- Microcirculation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Afeka, The Tel-Aviv Academic College of EngineeringUniversity, hospital or other
- Collaborators
- Hebrew University of Jerusalem
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 30 Nov 2017 (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 objective of the current study is to investigate the hemodynamic changes in the peripheral microcirculation system as a response to various changes, using noninvasive thermography and laser doppler
Detailed description
This study includes a single session per subject. Microvascular and systemic variables will be monitored in response to a number of non-invasive interventions/device that are approved for clinical use and known to elicit microvascular responses. These interventions are applied consecutively, include breathing at different rates, low power visible light in the red-to-near-infrared range, increase in local temperature, and changes in the arm position.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Red LED | Experimental | Device: Omnilux new-U (Red LED), Device: RESPeRATE, Device: Heating bagLight emitting diodes, 633 nm, 70 mW/cm2, Omnilux new-U (Red LED) (Photomedex, Horsham, PA, USA); RESPeRATE; Heating bag |
| Near Infrared LED | Active comparator | Device: Omnilux new-U (Near infrared LED), Device: RESPeRATE, Device: Heating bagLight emitting diodes, 830 nm, 55 mW/ cm2, Omnilux new-U (Near infrared LED) (Photomedex, Horsham, PA, USA); RESPeRATE metronome; Heating bag |
Who may qualify
- Ages
- 23 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy males and females, between 23 and 45 years of age.
- Willing to sign informed consent
Key exclusion criteria (7 listed)
- Currently smoking
- Any abnormal skin condition in the area of light irradiation.
- Pregnant having given birth less than 3 months ago, and/or breastfeeding.
- Having a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen.
- Having any illness that might affect the vasculature, such as diabetes (type I or II)
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 |
|---|---|---|
| Omnilux new-U (Red LED)The left wrist (including area of radial artery) will be illuminated with the Omnilux new-U (Red LED) light source, while the right wrist will not be illuminated | Device | Red LED |
| Omnilux new-U (Near infrared LED)The left wrist (including area of radial artery) will be illuminated with the Omnilux new-U (Near infrared LED) light source, while the right wrist will not be illuminated | Device | Near Infrared LED |
| RESPeRATEThe subjects will be guided by a digital metronome to breath at 15, 10, and 6 breaths/min for 2 minutes each using the metronome function of the device RESPeRATE (InterCure, Israel) that guides breathing using musical tones played at selectable rhythm | Device | Near Infrared LED, Red LED |
| Heating bagApplying a standard 10X13 [cm] heating bag on the surface of the hand at 43-45 degree Celsius for 10 seconds | Device | Near Infrared LED, Red LED |
Primary outcome
Capillary blood flow
Time frame: Up to 1 hour
Capillary blood flow (red blood cell velocity or flux in 'perfusion units') as measured by laser doppler (Biopac™ System, Inc, USA). This is a continuous measurement (at least 10 Hz sampling rate) from baseline to end of experiment.
2 secondary outcomes
Temperature distribution over hands measured by thermography
Time frame: Up to 1 hour
Tissue oxygenation (tcPO2)
Time frame: Up to 1 hour
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 10 Nov 2021.
- Derived from this study: PubMed 32064652Gavish L, Hoffer O, Rabin N, Halak M, Shkilevich S, Shayovitz Y, Weizman G, Haim O, Gavish B, Gertz SD, Ovadia-Blechman Z. Microcirculatory Response to Photobiomodulation-Why Some Respond and Others Do Not: A Randomized Controlled Study. Lasers Surg Med. 2020 Nov;52(9):863-872. doi: 10.1002/lsm.23225. Epub 2020 Feb 17.
- Individual participant dataSharing planned: No
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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.
Zehava Blechman, PhD principal investigator
Afeka Tel Aviv Academic College of Engineering
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omnilux new-U (Red LED), Omnilux new-U (Near infrared LED) and RESPeRATE in people with Microcirculation, run by Afeka, The Tel-Aviv Academic College of Engineering 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 7 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 10 Nov 2021. 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?
Capillary blood flow (time frame: Up to 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03357523, which also lists 1 linked publication.
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 10 Nov 2021.