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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Autoimmune Diseases, Sickle Cell Disease, Chronic Graft Versus Host Disease

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Trial Information

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


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.

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Microvascular density in oral mucosa and skin

Outcome Description:

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

Outcome Time Frame:

over 24 months

Safety Issue:

No

Principal Investigator

Keith Sullivan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University

Authority:

United States: Institutional Review Board

Study ID:

Pro00039256

NCT ID:

NCT01758250

Start Date:

February 2013

Completion Date:

January 2017

Related Keywords:

  • Autoimmune Diseases
  • Sickle Cell Disease
  • Chronic Graft Versus Host Disease
  • Autoimmune diseases with cutaneous involvement
  • Systemic sclerosis
  • Scleroderma
  • Morphea
  • Dermatomyositis
  • Cutaneous lupus
  • Vasculitis
  • Sickle Cell Disease
  • Graft versus Host Disease
  • Anemia, Sickle Cell
  • Autoimmune Diseases
  • Fibrosis
  • Graft vs Host Disease
  • Scleroderma, Systemic
  • Scleroderma, Diffuse

Name

Location
Duke University Medical Center Durham, North Carolina  27710