Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
63 participants
OBSERVATIONAL
2013-02-28
2018-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Optical Coherence Tomography Imaging in Systemic Sclerosis
NCT04532151
Longitudinal Spatial Frequency Domain Imaging Study
NCT05672992
Fibrosis, Inflammation, Oxygenation of Renal Tissue In FabrY Disease
NCT06325488
Diffuse Cutaneous Scleroderma (DSSc) SFDI Study
NCT07090226
Role of Eosinophil in Fibrogenesis of Systemic Sclerosis
NCT03816189
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Systemic Sclerosis
Patients with SSc will have imaging studies performed at baseline and at 3, 6, 9, 12, 15, 18, 21 and 24 months.
Acoustic Radiation Force Impulse (ARFI)
Laser Doppler Flowmetry (LDF)
Laser Doppler Perfusion Imaging (LDI)
Optical Coherence Tomography (OCT)
Orthogonal Polarization Spectral Imaging (OPSI)
Nail fold video capillaroscopy (NVC)
GVHD
Patients with GVHD will have imaging studies performed at baseline and at 3, 6, 9, 12, 18 and 24 months.
Acoustic Radiation Force Impulse (ARFI)
Laser Doppler Flowmetry (LDF)
Laser Doppler Perfusion Imaging (LDI)
Optical Coherence Tomography (OCT)
Orthogonal Polarization Spectral Imaging (OPSI)
Nail fold video capillaroscopy (NVC)
Undergoing HSCT
Patients who are about to undergo HSCT will have imaging studies performed at 1 week pre-transplantation, day 40 and 80 post transplantation and at 3 months, 6 months, 12 months 18 months and 24 months post-transplant.
Acoustic Radiation Force Impulse (ARFI)
Laser Doppler Flowmetry (LDF)
Laser Doppler Perfusion Imaging (LDI)
Optical Coherence Tomography (OCT)
Orthogonal Polarization Spectral Imaging (OPSI)
Nail fold video capillaroscopy (NVC)
Controls
Healthy Controls and Controls with hematologic and solid organ malignancies and dermatitis will have imaging studies performed at a single point in time.
Acoustic Radiation Force Impulse (ARFI)
Laser Doppler Flowmetry (LDF)
Laser Doppler Perfusion Imaging (LDI)
Optical Coherence Tomography (OCT)
Orthogonal Polarization Spectral Imaging (OPSI)
Nail fold video capillaroscopy (NVC)
Sickle cell disease
Patients with SCD will have imaging studies performed at baseline and at 3, 6, 9, 12, 15, 18, 21 and 24 months.
Acoustic Radiation Force Impulse (ARFI)
Laser Doppler Flowmetry (LDF)
Laser Doppler Perfusion Imaging (LDI)
Optical Coherence Tomography (OCT)
Orthogonal Polarization Spectral Imaging (OPSI)
Nail fold video capillaroscopy (NVC)
Cutaneous fibrosing disorder
Patients with active cutaneous fibrosing disorder will have imaging studies performed at a single point in time.
Acoustic Radiation Force Impulse (ARFI)
Laser Doppler Flowmetry (LDF)
Laser Doppler Perfusion Imaging (LDI)
Optical Coherence Tomography (OCT)
Orthogonal Polarization Spectral Imaging (OPSI)
Nail fold video capillaroscopy (NVC)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Acoustic Radiation Force Impulse (ARFI)
Laser Doppler Flowmetry (LDF)
Laser Doppler Perfusion Imaging (LDI)
Optical Coherence Tomography (OCT)
Orthogonal Polarization Spectral Imaging (OPSI)
Nail fold video capillaroscopy (NVC)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Control patients include normal healthy controls above the age of 18 who are capable of giving informed consent.
Exclusion Criteria
* Subjects unable to provide informed consent.
* Smokers, patients unable to tolerate caffeine avoidance for the day of the study.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Duke University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Keith Sullivan, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Adela Cardones, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Duke University Medical Center
Durham, North Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Pro00039256
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.