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Clinical Trials/NCT03357523
NCT03357523
Completed
N/A

Evaluation of Peripheral Microcirculation Hemodynamics Following Various Changes Based on Noninvasive Thermography: A Prospective, Randomized, Controlled Trial

Afeka, The Tel-Aviv Academic College of Engineering1 site in 1 country20 target enrollmentNovember 1, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Microcirculation
Sponsor
Afeka, The Tel-Aviv Academic College of Engineering
Enrollment
20
Locations
1
Primary Endpoint
Capillary blood flow
Status
Completed
Last Updated
4 years ago

Overview

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

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2017
End Date
December 31, 2019
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Afeka, The Tel-Aviv Academic College of Engineering
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Temperature distribution over hands measured by thermography(Up to 1 hour)
  • Tissue oxygenation (tcPO2)(Up to 1 hour)

Study Sites (1)

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