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NCT01758250 · ClinicalTrials.gov registry record
Microvascular and Fibrosis Imaging Study
A clinical trial, sponsored by Duke University.
- Completed
- Registry status
- 63
- Enrollment target
NCT01758250 is a clinical trial that has completed, run by Duke University. The registered enrollment target is 63 participants.
The verdict
NCT01758250 has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- 63 participants
- Enrollment target
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.
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)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2013-02 |
| Est. Completion | 2018-02 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01758250
The ClinicalTrials.gov registry entry for NCT01758250 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Acoustic Radiation Force Impulse (ARFI) is the first listed.
NCT01758250 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01758250 about?
NCT01758250 is a clinical study titled "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 ...
What is the current status of trial NCT01758250?
This trial is currently completed. The enrollment target is 63 participants. The study started on 2013-02. Estimated completion is 2018-02.
What interventions are being tested in trial NCT01758250?
The interventions under investigation include: 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).
Who is sponsoring clinical trial NCT01758250?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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