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LSFG-SKIN, Laser Speckle Flowgraphy

LSFG-SKIN, Laser Speckle Flowgraphy

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03660618
Enrollment
1
Registered
2018-09-06
Start date
2017-05-23
Completion date
2019-03-02
Last updated
2023-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autonomic Neuropathy, Burns, Chemotherapy Effect, Headache, Heart Failure, Hypertension, Intracranial Hemorrhages, Migraine, Multiple Sclerosis, Pain, Radiation Injuries, Scleritis, Stroke, TIA, Uveitis, Vascular Ischemia

Keywords

perfusion, inflammatory, ischemia, lesions, neuropathy, burns, cancer, stroke

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.

Interventions

blood flow state of the skin as real time two dimensional image

Sponsors

Randy Kardon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Imaging Blood FlowOne visitImaging blood flow in the tissue is of major importance in the clinical environment

Countries

United States

Participant flow

Participants by arm

ArmCount
Clinic Subjects
cardiology subjects, dermatology subjects, endocrine subjects, neurology subjects, psychiatry subjects, surgery subjects, ophthalmology subjects. laser speckle flowgraphy: blood flow state of the skin as real time two dimensional image
1
Total1

Baseline characteristics

CharacteristicClinic Subjects
Age, Continuous55 years
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
1 Participants
Sex: Female, Male
Female
1 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 1
other
Total, other adverse events
0 / 1
serious
Total, serious adverse events
0 / 1

Outcome results

Primary

Imaging Blood Flow

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

Time frame: One visit

Population: One subject tested before device had to be returned due to company going out of business. Data was not measurable and no repeat testing was possible as device was returned.

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026