Scleroderma ARFI Imaging of the Skin

Study Results

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Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Scleroderma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ARFI-SVI Ultrasound

Ultrasound imaging of forearm and thigh, lasting approximately 5-10 minutes.

ARFI-SVI Ultrasound

Intervention Type DEVICE

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.

ARFI-SVI Ultrasound

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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)