Clinical trial NCT02006420: Scleroderma ARFI Imaging of the Skin
Official title: Acoustic Radiation Force Impulse/Shear Wave Velocity Imaging of the Skin in Scleroderma and Other Rheumatologic Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Scleroderma
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2013-12-10
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects are people aged 18 or over who are either healthy or who have scleroderma or another rheumatological condition.

Brief summary: Scleroderma and other rheumatologic conditions can affect the skin. Scleroderma in particular involves skin thickening and hardening.

Currently, looking at the degree that the skin is affected by scleroderma is measured based on a combination of a physical exam and a skin biopsy.

The researchers propose to measure skin hardness using ultrasound imaging of elasticity. They will use a technique using acoustic radiation force impulse/shear wave velocity imaging , known as ARFI/SVI).

The investigators hypothesize that ARFI/SVI may be able to distinguish between normal skin and skin affected by scleroderma.. This tool may also help to quantify the amount of fibrosis in the skin.

This type of radiologic biomarker could be used to help confirm the diagnosis of scleroderma.

Detailed description: Scleroderma as well as numerous other rheumatologic conditions can affect the skin. Scleroderma in particular causes skin thickening and hardening.

Currently, evaluation of degree to which skin is affected by scleroderma is measured by a combination of a physical exam and skin biopsy results.

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). And, this ultrasound technique might measure the amount of fibrosis in the dermis (skin).

Such a radiologic biomarker could be used to help confirm the diagnosis of scleroderma. In addition, it may be usable for following patients over time and measuring their response to therapy and progression of disease.

Eligibility 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

Primary outcomes:
measure: Mean Skin Stiffness
timeFrame: Cross-sectional study, 1 visit, <1 hr
Secondary outcomes:
measure: Mean Skin Stiffness as Measured by Durometer Scoring
timeFrame: Cross-sectional study, 1 visit, <1 hr
measure: Linear Relationship Between Ultrasound Skin Stiffness and Durometer
timeFrame: Cross-sectional study, 1 visit, <1 hr
measure: Mean Landmark Scores
timeFrame: Cross-sectional study, 1 visit, <1 hr
measure: Linear Relationship Between Ultrasound Skin Stiffness and Landmark
timeFrame: Cross-sectional study, 1 visit, <1 hr
measure: MRSS Scores for Scleroderma Participants.
timeFrame: Cross-sectional study, 1 visit, <1 hr
measure: Linear Relationship Between Ultrasound Skin Stiffness and MRSS
timeFrame: Cross-sectional study, 1 visit, <1 hr
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
Study officials:
References: