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LSFG-SKIN, Laser Speckle Flowgraphy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03660618
Recruitment Status : Completed
First Posted : September 6, 2018
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
Randy Kardon, University of Iowa

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.

Condition or disease Intervention/treatment Phase
Hypertension Heart Failure Vascular Ischemia Burns Chemotherapy Effect Radiation Injuries Uveitis Scleritis Multiple Sclerosis Autonomic Neuropathy Stroke Intracranial Hemorrhages TIA Migraine Headache Pain Device: laser speckle flowgraphy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: LSFG-SKIN, Laser Speckle Flowgraphy
Actual Study Start Date : May 23, 2017
Actual Primary Completion Date : March 2, 2018
Actual Study Completion Date : March 2, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Laser Speckle Skin Blood Flow [ Time Frame: 30 minutes ]
    explore how spatial and temporal variations in skin blood flow reveal the status of stated systems.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03660618


Locations
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United States, Iowa
University of Iowa Department of Ophthalmology
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa

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Responsible Party: Randy Kardon, Randy Kardon M.D. Ph.D Professor and Director of Neuro-ophthalmology, University of Iowa
ClinicalTrials.gov Identifier: NCT03660618     History of Changes
Other Study ID Numbers: 201702725
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Randy Kardon, University of Iowa:
perfusion
inflammatory
ischemia
lesions
neuropathy
burns
cancer
stroke

Additional relevant MeSH terms:
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Heart Failure
Multiple Sclerosis
Hemorrhage
Ischemia
Headache
Uveitis
Intracranial Hemorrhages
Radiation Injuries
Scleritis
Heart Diseases
Cardiovascular Diseases
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Uveal Diseases
Eye Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Wounds and Injuries
Scleral Diseases