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Microvascular and Fibrosis Imaging Study

NCT01758250 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 63

Last updated 2020-09-11

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

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)

Sponsors & Collaborators

Principal Investigators

  • Keith Sullivan, MD · Duke University

  • Adela Cardones, MD · Duke University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2018-02-28
Completion
2018-02-28

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01758250 on ClinicalTrials.gov