Microvascular and Fibrosis Imaging Study



Status:Recruiting
Conditions:Infectious Disease, Anemia, Hematology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery, Hematology, Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:2/9/2019
Start Date:February 2013
End Date:December 2019
Contact:Margaret (Peggy) Eren, RN
Email:eren0001@mc.duke.edu
Phone:919-668-1047

Use our guide to learn which trials are right for you!

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

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.


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.
We found this trial at
1
site
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
?
mi
from
Durham, NC
Click here to add this to my saved trials