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Scleroderma ARFI Imaging of the Skin (ARFI)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02006420
First Posted: December 10, 2013
Last Update Posted: January 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jonathan R. Dillman M.D., University of Michigan
  Purpose
Scleroderma as well as numerous other rheumatologic conditions can affect the skin. Scleroderma in particular involves skin thickening and hardening. Currently, evaluation of skin involvement by scleroderma is assessed based on a combination of physical examination and histologic assessment after biopsy. The investigators propose to measure skin hardness using ultrasound elasticity imaging, in the form of acoustic radiation force impulse/shear wave velocity imaging (ARFI/SVI). The investigators hypothesize that ARFI/SVI may be able to distinguish normal skin from skin affected by scleroderma (and other rheumatologic conditions) as well as perhaps quantify the amount of fibrosis in the dermis. Such a radiologic biomarker could be used to help confirm the diagnosis of scleroderma as well as to follow patients over time and assess response to therapy and progression of disease.

Condition Intervention
Scleroderma Device: ARFI-SVI Ultrasound

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Acoustic Radiation Force Impulse/Shear Wave Velocity Imaging of the Skin in Scleroderma and Other Rheumatologic Diseases

Resource links provided by NLM:


Further study details as provided by Jonathan R. Dillman M.D., University of Michigan:

Primary Outcome Measures:
  • Skin shear wave speed measurements (forearm and thigh) [ Time Frame: 1 year ]
    We will measure skin thickness from the forearm and thigh of patients with scleroderma using ultrasound shear wave velocity imaging.


Secondary Outcome Measures:
  • Durometer scoring [ Time Frame: 1 year ]
    We will look for correlation/association between ultrasound skin measurements with durometer scoring.

  • Subjective skin scoring [ Time Frame: 1 year ]
    We will look for correlation/association between ultrasound skin measurements with subjective skin scoring (e.g., Landmark and Modified Rodnan Skin Score, or MRSS)


Enrollment: 45
Study Start Date: December 2013
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARFI-SVI Ultrasound
Ultrasound imaging of forearm and thigh, lasting approximately 5-10 minutes.
Device: ARFI-SVI Ultrasound
Ultrasound imaging of arm and leg lasting approximately 5-10 minutes. Participants will also undergo durometer scoring on the forearm and thigh as part of the study. This lasts approximately 5-10 minutes.
Experimental: Healthy Volunteers: AFRI/SVI Ultrasound
Ultrasound imaging of forearm and thigh, lasting approximately 5-10 minutes.
Device: ARFI-SVI Ultrasound
Ultrasound imaging of arm and leg lasting approximately 5-10 minutes. Participants will also undergo durometer scoring on the forearm and thigh as part of the study. This lasts approximately 5-10 minutes.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 18 years of age or older
  2. Rheumatologic disease of the skin including: Limited Scleroderma, Diffuse Scleroderma, or Eosinophilic Fascitis (Schulman's Syndrome)

Exclusion Criteria:

1. None

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02006420


Locations
United States, Michigan
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
  More Information

Responsible Party: Jonathan R. Dillman M.D., Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT02006420     History of Changes
Other Study ID Numbers: HUM00074229
First Submitted: November 26, 2013
First Posted: December 10, 2013
Last Update Posted: January 30, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Connective Tissue Diseases
Skin Diseases