Scleroderma ARFI Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Jonathan R. Dillman M.D., University of Michigan
ClinicalTrials.gov Identifier:
NCT02006420
First received: November 26, 2013
Last updated: June 5, 2014
Last verified: June 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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 University of Michigan:

Primary Outcome Measures:
  • Skin shear wave speed measurements (forearm and thigh) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    We will look for correlation/association between ultrasound skin measurements with durometer scoring.

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


Estimated Enrollment: 200
Study Start Date: November 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02006420

Locations
United States, Michigan
University of Michigan Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Jonathan R Dillman, MD    734-232-9247    jonadill@umich.edu   
Contact: James W Pool, Jr., CCRC    734-615-7391    jampool@umich.edu   
Principal Investigator: Jonathan R Dillman, MD         
Sub-Investigator: Dinesh Khanna, MD         
Sponsors and Collaborators
University of Michigan
  More Information

No publications provided

Responsible Party: Jonathan R. Dillman M.D., Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT02006420     History of Changes
Other Study ID Numbers: HUM00074229
Study First Received: November 26, 2013
Last Updated: June 5, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 01, 2014