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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03660618
Other study ID # 201702725
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date May 23, 2017
Est. completion date March 2, 2019

Study information

Verified date May 2023
Source University of Iowa
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 1
Est. completion date March 2, 2019
Est. primary completion date March 2, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility 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 Design


Intervention

Device:
laser speckle flowgraphy
blood flow state of the skin as real time two dimensional image

Locations

Country Name City State
United States University of Iowa Department of Ophthalmology Iowa City Iowa

Sponsors (1)

Lead Sponsor Collaborator
Randy Kardon

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Imaging Blood Flow Imaging blood flow in the tissue is of major importance in the clinical environment One visit
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