NCT03357523

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 30, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

November 10, 2021

Status Verified

November 1, 2021

Enrollment Period

7 months

First QC Date

November 20, 2017

Last Update Submit

November 8, 2021

Conditions

Microcirculation

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 1 hour

Secondary Outcomes (2)

  • Temperature distribution over hands measured by thermography

    Up to 1 hour

  • Tissue oxygenation (tcPO2)

    Up to 1 hour

Study Arms (2)

Red LED

EXPERIMENTAL

Light emitting diodes, 633 nm, 70 mW/cm2, Omnilux new-U (Red LED) (Photomedex, Horsham, PA, USA); RESPeRATE; Heating bag

Device: Omnilux new-U (Red LED)Device: RESPeRATEDevice: 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

Device: Omnilux new-U (Near infrared LED)Device: RESPeRATEDevice: Heating bag

Interventions

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

Red LED
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

Near Infrared LED
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

Near Infrared LEDRed LED
Heating bagDEVICE

Applying a standard 10X13 \[cm\] heating bag on the surface of the hand at 43-45 degree Celsius for 10 seconds

Near Infrared LEDRed LED

Eligibility Criteria

Age23 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy males and females, between 23 and 45 years of age.
  • Willing to sign informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Afeka, Tel-Aviv Academic College of Engineering

Tel Aviv, Israel

Location

Related Publications (1)

  • 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.

    PMID: 32064652DERIVED

Study Officials

  • Zehava Blechman, PhD

    Afeka Tel Aviv Academic College of Engineering

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2017

First Posted

November 30, 2017

Study Start

November 1, 2017

Primary Completion

June 1, 2018

Study Completion

December 31, 2019

Last Updated

November 10, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)