Scleroderma ARFI Imaging of the Skin

Completed

• Conditions: Scleroderma
• Interventions: Device: ARFI-SVI Ultrasound

• Registration Number: NCT02006420
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study First Submitted: 2013-11-26
• Study Start: 2013-12
• Study First Submitted QC: 2013-12-04
• Study First Posted: 2013-12-10
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Results First Submitted: 2018-03-06
• Status Verified: 2019-04
• Results First Submitted QC: 2019-04-17
• Last Update Submitted: 2019-04-17
• Results First Posted: 2019-07-05
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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)

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Exclusion Criteria

1. None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ARFI-SVI Ultrasound	ARFI-SVI Ultrasound	Ultrasound imaging of forearm and thigh, lasting approximately 5-10 minutes.
Healthy Volunteers: ARFI/SVI Ultrasound	ARFI-SVI Ultrasound	Ultrasound imaging of forearm and thigh, lasting approximately 5-10 minutes.

Primary Outcome Measures

Name	Time	Method
Mean Skin Stiffness	Cross-sectional study, 1 visit, <1 hr	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).

Secondary Outcome Measures

Name	Time	Method
Mean Skin Stiffness as Measured by Durometer Scoring	Cross-sectional study, 1 visit, <1 hr	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.
Linear Relationship Between Ultrasound Skin Stiffness and MRSS	Cross-sectional study, 1 visit, <1 hr	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.
Linear Relationship Between Ultrasound Skin Stiffness and Durometer	Cross-sectional study, 1 visit, <1 hr	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.
Mean Landmark Scores	Cross-sectional study, 1 visit, <1 hr	Mean Landmark scores are on a scale of 0 to 3, 0 = normal and 3 =marked skin hardening.
Linear Relationship Between Ultrasound Skin Stiffness and Landmark	Cross-sectional study, 1 visit, <1 hr	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.
MRSS Scores for Scleroderma Participants.	Cross-sectional study, 1 visit, <1 hr	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.

Trial Locations

Locations (1)

University of Michigan Hospital; 🇺🇸 Ann Arbor, Michigan, United States