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Completed

NCT Number: NCT01758250

Microvascular and Fibrosis Imaging Study

In this study, Laser Doppler Flowmetry (LDF), Laser Doppler Imaging (LDI), Orthogonal Polarization Spectral Imaging (OPSI), Nail fold video capillaroscopy (NVC) and Optical Coherence Tomography (OCT) will be used to assess differences in microvascular function and density of oral mucosa and skin in subjects with 1) autoimmune diseases with cutaneous involvement: systemic sclerosis (SSc), morphea, dermatomyositis, cutaneous lupus and vasculitis, 2) sickle cell disease (SCD) and 3) chronic graft-versus-host disease (GVHD) compared to healthy subjects. The microvascular changes will be compared to overall treatment response in patients with scleroderma and chronic GVHD as assessments will be made before and after the patients start treatment for their diseases and determine if these imaging techniques provide valuable and reproducible data when assessing a patient's response to treatment for those diseases. In addition, the application of Acoustic Radiation Force Impulse (ARFI) in determining cutaneous thickness in patients with SSc, GVHD and morphea will be evaluated.

The investigators hypothesize that the vascular and dermal structures are altered in patients with autoimmune disease, SCD and chronic GVHD. In addition, they hypothesize that imaging modalities such as LDF, LDI, OCT, NVC, OPSI and ARFI can quantify such structural alterations and can be used to 1) detect early disease activity, 2) quantify and assess response to therapy and 3) quantify and correlate with overall disease activity.

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Key information

Conditions

Autoimmune Diseases Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Cardiovascular Diseases Chronic Graft Versus Host Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Dermatomyositis Genetic Diseases, Inborn Graft vs Host Disease Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Immune System Diseases Lung Diseases Lung Diseases, Obstructive Muscular Diseases Musculoskeletal Diseases Myositis Nervous System Diseases Neuromuscular Diseases Organizing Pneumonia Polymyositis Respiratory Tract Diseases Scleroderma, Diffuse Scleroderma, Localized Scleroderma, Systemic Sickle Cell Disease Skin Diseases Skin and Connective Tissue Diseases Vascular Diseases Vasculitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects above the age of 18 who are capable of giving informed consent with one of the following conditions: Scleroderma, Graft vs Host Disease, Sickle Cell Disease, Morphea, Connective Tissue Disease with cutaneous manifestations: cutaneous lupus, dermatomyositis, vasculitis, patients who are undergoing HSCT, or patients with a diagnosis of hematologic and non-hematologic malignancies without GVHD
  • Control patients include normal healthy controls above the age of 18 who are capable of giving informed consent.

Exclusion criteria

  • Patients who experience discomfort, will be prone to experience discomfort or cannot tolerate the position required for the imaging studies.
  • Subjects unable to provide informed consent.
  • Smokers, patients unable to tolerate caffeine avoidance for the day of the study.

Treatment and study plan

Acoustic Radiation Force Impulse (ARFI)

Other

Laser Doppler Flowmetry (LDF)

Other

Laser Doppler Perfusion Imaging (LDI)

Other

Optical Coherence Tomography (OCT)

Other

Orthogonal Polarization Spectral Imaging (OPSI)

Other

Nail fold video capillaroscopy (NVC)

Other

Primary outcomes

  1. Microvascular density in oral mucosa and skin

    Time frame: over 24 months

    Microvascular density as evaluated using LDF, LDI, OPSI, OCT, NVC and AFRI, will be compared between subjects with and without disease.

  2. Microvascular Perfusion in oral mucosa and skin

    Time frame: over 24 months

    Microvascular perfusion as evaluated using LDF, LDI, OPSI, OCT, NVC, and AFRI, will be compared between subjects with and without disease.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Mechanistic Study: Non-Invasive Cutaneous Microvascular and Fibrosis Imaging of Patients With Systemic Sclerosis, Sickle Cell Disease and Chronic Graft-Versus-Host Disease (GVHD) Compared to Healthy Subjects

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Jan 1, 2013
Registry last updated
Sep 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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