Back to resultsLSFG-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
About this trial
This is an interventional treatment trial for Hypertension focused on measuring perfusion, inflammatory, ischemia, lesions, neuropathy, burns, cancer, stroke
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
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
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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