NCT01758250

Microvascular and Fibrosis Imaging Study

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 63 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

• Autoimmune Diseases
• Sickle Cell Disease
• Chronic Graft Versus Host Disease

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2013-02-01
• Primary completion: 2018-02-01
• Completion: 2018-02-01
• First posted: 2013-01-01
• Last updated: 2020-09-11

Locations

1 site across 1 country: United States