Autoimmune DiseasesNCT01758250
Microvascular and Fibrosis Imaging Study
An observational study of Autoimmune Diseases and Sickle Cell Disease, run by Duke University at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autoimmune Diseases, Sickle Cell Disease, Chronic Graft Versus Host Disease
- What is being tested?
- Acoustic Radiation Force Impulse (ARFI), Laser Doppler Flowmetry (LDF) and Laser Doppler Perfusion Imaging (LDI)
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patient population at Duke University Medical Center and healthy controls
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: 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.
- Being tested
- Acoustic Radiation Force Impulse (ARFI), Laser Doppler Flowmetry (LDF), Laser Doppler Perfusion Imaging (LDI), Optical Coherence Tomography (OCT), Orthogonal Polarization Spectral Imaging (OPSI)
- Keywords
- Autoimmune diseases with cutaneous involvement, Systemic sclerosis, Scleroderma, Morphea, Dermatomyositis, Cutaneous lupus, Vasculitis, Sickle Cell Disease, Graft versus Host Disease
- Medical subject headings
- Autoimmune Diseases, Anemia, Sickle Cell, Bronchiolitis Obliterans Syndrome, Scleroderma, Systemic, Scleroderma, Diffuse, Scleroderma, Localized, Dermatomyositis, Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)Other
| Study group | Role | What they receive |
|---|---|---|
| Systemic Sclerosis | Patients with SSc will have imaging studies performed at baseline and at 3, 6, 9, 12, 15, 18, 21 and 24 months. Receives: 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) | |
| GVHD | Patients with GVHD will have imaging studies performed at baseline and at 3, 6, 9, 12, 18 and 24 months. Receives: 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) | |
| 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. Receives: 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) | |
| Controls | Healthy Controls and Controls with hematologic and solid organ malignancies and dermatitis will have imaging studies performed at a single point in time. Receives: 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) | |
| 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. Receives: 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) | |
| Cutaneous fibrosing disorder | Patients with active cutaneous fibrosing disorder will have imaging studies performed at a single point in time. Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microvascular density in oral mucosa and skin
Microvascular density as evaluated using LDF, LDI, OPSI, OCT, NVC and AFRI, will be compared between subjects with and without disease.
Measured: over 24 months
Microvascular Perfusion in oral mucosa and skin
Microvascular perfusion as evaluated using LDF, LDI, OPSI, OCT, NVC, and AFRI, will be compared between subjects with and without disease.
Measured: over 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiseasesStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keith Sullivan, MD, Principal investigator, Duke UniversityAdela Cardones, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01758250
- Sponsor's protocol ID
- Pro00039256
- Status last verified
- May 2020
- First submitted
- 26 Dec 2012
- Last updated
- 11 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01758250
- Acronym / sponsor ID
- Pro00039256
- Keywords
- Autoimmune diseases with cutaneous involvement, Systemic sclerosis, Scleroderma, Morphea, Dermatomyositis, Cutaneous lupus, Vasculitis, Sickle Cell Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Feb 2013 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 1 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Systemic Sclerosis | – | 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)Patients with SSc will have imaging studies performed at baseline and at 3, 6, 9, 12, 15, 18, 21 and 24 months. |
| GVHD | – | 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)Patients with GVHD will have imaging studies performed at baseline and at 3, 6, 9, 12, 18 and 24 months. |
| Undergoing HSCT | – | 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)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. |
| Controls | – | 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)Healthy Controls and Controls with hematologic and solid organ malignancies and dermatitis will have imaging studies performed at a single point in time. |
| Sickle cell disease | – | 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)Patients with SCD will have imaging studies performed at baseline and at 3, 6, 9, 12, 15, 18, 21 and 24 months. |
| Cutaneous fibrosing disorder | – | 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)Patients with active cutaneous fibrosing disorder will have imaging studies performed at a single point in time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patient population at Duke University Medical Center and healthy controls
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acoustic Radiation Force Impulse (ARFI) | Other | Controls, Cutaneous fibrosing disorder, GVHD, Sickle cell disease, Systemic Sclerosis, Undergoing HSCT |
| Laser Doppler Flowmetry (LDF) | Other | Controls, Cutaneous fibrosing disorder, GVHD, Sickle cell disease, Systemic Sclerosis, Undergoing HSCT |
| Laser Doppler Perfusion Imaging (LDI) | Other | Controls, Cutaneous fibrosing disorder, GVHD, Sickle cell disease, Systemic Sclerosis, Undergoing HSCT |
| Optical Coherence Tomography (OCT) | Other | Controls, Cutaneous fibrosing disorder, GVHD, Sickle cell disease, Systemic Sclerosis, Undergoing HSCT |
| Orthogonal Polarization Spectral Imaging (OPSI) | Other | Controls, Cutaneous fibrosing disorder, GVHD, Sickle cell disease, Systemic Sclerosis, Undergoing HSCT |
| Nail fold video capillaroscopy (NVC) | Other | Controls, Cutaneous fibrosing disorder, GVHD, Sickle cell disease, Systemic Sclerosis, Undergoing HSCT |
Primary outcome
Microvascular density in oral mucosa and skin
Time frame: over 24 months
Microvascular density as evaluated using LDF, LDI, OPSI, OCT, NVC and AFRI, will be compared between subjects with and without disease.
Microvascular Perfusion in oral mucosa and skin
Time frame: over 24 months
Microvascular perfusion as evaluated using LDF, LDI, OPSI, OCT, NVC, and AFRI, will be compared between subjects with and without disease.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith Sullivan, MD principal investigator
Duke University
Adela Cardones, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Diseases and Sickle Cell Disease, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microvascular density in oral mucosa and skin (time frame: over 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2020.