Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for all trials

Timeline

Completed

Started Feb 2013

Longer than P75 for all trials

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5 years study duration

First Submitted

Initial submission to the registry

December 26, 2012

Completed

6 days until next milestone

First Posted

Study publicly available on registry

January 1, 2013

Completed

1 month until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed

5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed

Last Updated

September 11, 2020

Status Verified

May 1, 2020

Enrollment Period

5 years

First QC Date

December 26, 2012

Last Update Submit

September 10, 2020

Conditions

Autoimmune Diseases Sickle Cell Disease Chronic Graft Versus Host Disease

Keywords

Autoimmune diseases with cutaneous involvementSystemic sclerosisSclerodermaMorpheaDermatomyositisCutaneous lupusVasculitisSickle Cell DiseaseGraft versus Host Disease

Outcome Measures

Primary Outcomes (2)

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.
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.
over 24 months

Study Arms (6)

Systemic Sclerosis

Patients with SSc will have imaging studies performed at baseline and at 3, 6, 9, 12, 15, 18, 21 and 24 months.

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.

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.

Controls

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

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

Patients with active cutaneous fibrosing disorder will have imaging studies performed at a single point in time.