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LSFG-SKIN, Laser Speckle Flowgraphy

Primary Purpose

Hypertension, Heart Failure, Vascular Ischemia

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
laser speckle flowgraphy
Sponsored by
Randy Kardon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring perfusion, inflammatory, ischemia, lesions, neuropathy, burns, cancer, stroke

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Iowa Department of Ophthalmology

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Clinic Subjects

Arm Description

cardiology subjects, dermatology subjects, endocrine subjects, neurology subjects, psychiatry subjects, surgery subjects, ophthalmology subjects.

Outcomes

Primary Outcome Measures

Imaging Blood Flow
Imaging blood flow in the tissue is of major importance in the clinical environment

Secondary Outcome Measures

Full Information

First Posted
July 12, 2018
Last Updated
May 9, 2023
Sponsor
Randy Kardon
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1. Study Identification

Unique Protocol Identification Number
NCT03660618
Brief Title
LSFG-SKIN, Laser Speckle Flowgraphy
Official Title
LSFG-SKIN, Laser Speckle Flowgraphy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
This study was stopped 3/2/18 as the company who supported the device went out of business and requested the device be returned. Only 1 control subject was tested, no analyzable data.
Study Start Date
May 23, 2017 (Actual)
Primary Completion Date
March 2, 2019 (Actual)
Study Completion Date
March 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Randy Kardon

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Heart Failure, Vascular Ischemia, Burns, Chemotherapy Effect, Radiation Injuries, Uveitis, Scleritis, Multiple Sclerosis, Autonomic Neuropathy, Stroke, Intracranial Hemorrhages, TIA, Migraine, Headache, Pain
Keywords
perfusion, inflammatory, ischemia, lesions, neuropathy, burns, cancer, stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clinic Subjects
Arm Type
Other
Arm Description
cardiology subjects, dermatology subjects, endocrine subjects, neurology subjects, psychiatry subjects, surgery subjects, ophthalmology subjects.
Intervention Type
Device
Intervention Name(s)
laser speckle flowgraphy
Intervention Description
blood flow state of the skin as real time two dimensional image
Primary Outcome Measure Information:
Title
Imaging Blood Flow
Description
Imaging blood flow in the tissue is of major importance in the clinical environment
Time Frame
One visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University of Iowa Department of Ophthalmology
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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LSFG-SKIN, Laser Speckle Flowgraphy

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