LSFG-SKIN, Laser Speckle Flowgraphy

May 9, 2023 updated by: Randy Kardon
The purpose of this project is to quantify normal and abnormal skin blood flow regionally in different areas of the body(face, extremities, over burns and wounds) at baseline and over time in response to treatment or environmental changes, such as temperature, light and pressure.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Laser speckle skin blood flow (LSFG-SKIN) will be recorded in normal subjects and in patients with disorders affecting skin capillary perfusion, which may include cardiovascular disorders, dermatologic disorders, skin wounds, ocular disorders, psychiatric disorders, and neurologic disorders.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Department of Ophthalmology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Controls

●Healthy normal control subjects ages 18-90

Cardiology Subjects

  • Ages 18-90
  • History of dysrhythmia, heart failure, cardiac ischemia, hypertension, peripheral vascular disease

Dermatology Subjects

  • Ages 18-90
  • History of inflammatory and cancerous lesions

Endocrine Subjects

  • Ages 18-90
  • History of diabetes, thyroid disease

Neurology Subjects

  • Ages 18-90
  • History of dementia, headaches, Parkinson's, light sensitivity, stroke, TIA, multiple sclerosis

Psychiatry Subjects

  • Ages 18-90
  • History of bipolar, schizophrenia, anxiety, depression

Surgery Subjects

  • Ages 18-90
  • History of skin wounds(trauma, chemotherapy, radiation), thermal burns, or plastic and reconstructive surgical procedures.

Ophthalmology Subjects

  • Ages 18-90
  • History of ocular disorders caused by hypo perfusion or inflammatory disorders

Exclusion Criteria:

Controls

  • Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.
  • Angle closure glaucoma

Cardiology Subjects

  • Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.

  • Angle closure glaucoma

    3. Dermatology Subjects

  • Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.
  • Angle closure glaucoma

Endocrine Subjects

  • Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.
  • Angle closure glaucoma

Neurology Subjects

  • Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.
  • Angle closure glaucoma

Psychiatry Subjects

  • Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.
  • Angle closure glaucoma

Surgery Subjects

  • Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.
  • Angle closure glaucoma

Ophthalmology Subjects

  • Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.
  • Angle closure glaucoma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Clinic Subjects
cardiology subjects, dermatology subjects, endocrine subjects, neurology subjects, psychiatry subjects, surgery subjects, ophthalmology subjects.
Device: laser speckle flowgraphy
blood flow state of the skin as real time two dimensional image

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Imaging Blood Flow
Time Frame: One visit
Imaging blood flow in the tissue is of major importance in the clinical environment
One visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Randy Kardon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2017

Primary Completion (Actual)

March 2, 2019

Study Completion (Actual)

March 2, 2019

Study Registration Dates

First Submitted

July 12, 2018

First Submitted That Met QC Criteria

September 4, 2018

First Posted (Actual)

September 6, 2018

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201702725

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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