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Evaluation of Peripheral Microcirculation Hemodynamics Following Various Changes Based on Noninvasive Thermography (MRT02)

A

Afeka, The Tel-Aviv Academic College of Engineering

Status

Completed

Conditions

Microcirculation

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03357523
05.04.2017-1-AFK

Details and patient eligibility

About

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

Full 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.

Enrollment

20 patients

Sex

All

Ages

23 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  1. Currently smoking
  2. Any abnormal skin condition in the area of light irradiation.
  3. Pregnant having given birth less than 3 months ago, and/or breastfeeding.
  4. 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.
  5. Having any illness that might affect the vasculature, such as diabetes (type I or II)
  6. Suffering from significant concurrent illness, such as cardiac disorders or pertinent neurological disorders.
  7. 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 design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

20 participants in 2 patient groups

Red LED
Experimental group
Description:
Light emitting diodes, 633 nm, 70 mW/cm2, Omnilux new-U (Red LED) (Photomedex, Horsham, PA, USA); RESPeRATE; Heating bag
Treatment:
Device: Omnilux new-U (Red LED)
Device: RESPeRATE
Device: Heating bag
Near Infrared LED
Active Comparator group
Description:
Light emitting diodes, 830 nm, 55 mW/ cm2, Omnilux new-U (Near infrared LED) (Photomedex, Horsham, PA, USA); RESPeRATE metronome; Heating bag
Treatment:
Device: Omnilux new-U (Near infrared LED)
Device: RESPeRATE
Device: Heating bag

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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