Scleroderma ARFI Imaging of the Skin (ARFI)

Acoustic Radiation Force Impulse/Shear Wave Velocity Imaging of the Skin in Scleroderma and Other Rheumatologic Diseases

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.

Study Overview

• Status: Completed
• Conditions: Scleroderma
• Intervention / Treatment: Device: ARFI-SVI Ultrasound

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.

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.
Healthy Volunteers: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Skin Stiffness	Skin stiffness was measured from the forearm and thigh of patients with scleroderma using ultrasound shear wave velocity imaging. Shear wave velocity is measured in meters per second (m/s).	Cross-sectional study, 1 visit, <1 hr

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Skin Stiffness as Measured by Durometer Scoring	Durometer scoring of skin stiffness in two groups of patients (controls and scleroderma). Durometer measurements are expressed in standardized international durometer units ranging from 0 to 100 where 100 is harder (worse outcome) The Rex Gauge model DD-3 was used. For further reference see Arthritis and Rheumatism (Arthritis Care & Research) Vol. 55. No. 4, August 15, 2006, pp. 603-609. DOI 10.1002/art.22093.	Cross-sectional study, 1 visit, <1 hr
Linear Relationship Between Ultrasound Skin Stiffness and Durometer	Pearson correlation assesses the linear relationship between Ultrasound skin stiffness measurements and Durometer scoring of skin stiffness. Data was combined for scleroderma and control subjects to assess the relationship and association across a broad range of skin conditions.	Cross-sectional study, 1 visit, <1 hr
Mean Landmark Scores	Mean Landmark scores are on a scale of 0 to 3, 0 = normal and 3 =marked skin hardening.	Cross-sectional study, 1 visit, <1 hr
Linear Relationship Between Ultrasound Skin Stiffness and Landmark	Pearson correlation assesses the linear relationship between ultrasound skin stiffness and subjective skin scoring (Landmark) of skin stiffness in all patients (controls plus scleroderma). Data was combined for scleroderma and control subjects to assess the relationship and association across a broad range of skin conditions.	Cross-sectional study, 1 visit, <1 hr
MRSS Scores for Scleroderma Participants.	MRSS scores exist on a scale from 0 to 51 based on scores of 0 to 3 measured in 17 locations on the body, where 0 represents overall healthy skin and 51 would be the worst outcome in all 17 locations. MRSS measures are not taken on healthy participants.	Cross-sectional study, 1 visit, <1 hr
Linear Relationship Between Ultrasound Skin Stiffness and MRSS	Pearson correlation assesses the linear relationships between ultrasound skin stiffness and subjective skin scoring (MRSS) of skin stiffness. MRSS is the Modified Rodnan Score. Skin thickness is measured by clinical palpation using a 0-3 scale. 0 = normal skin; 1 = mild thickness; 2 = moderate thickness; 3 = severe thickness with inability to pinch the skin into a fold. Because MRSS measurements were not taken for healthy participants, no correlations are provided for them. Therefore, the correlations are based on a skin stiffness and skin scoring solely for scleroderma participants.	Cross-sectional study, 1 visit, <1 hr

Collaborators and Investigators

• Sponsor: University of Michigan

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: November 26, 2013
• First Submitted That Met QC Criteria: December 4, 2013
• First Posted (Estimate): December 10, 2013

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: April 17, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Connective Tissue Diseases; Scleroderma, Systemic; Scleroderma, Diffuse; Scleroderma, Localized
• Other Study ID Numbers: HUM00074229

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No