Scleroderma ARFI Imaging of the Skin

NCT02006420 | Completed Results DMC

• 1 other identifier: HUM00074229
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Scleroderma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Mean Skin Stiffness as Measured by Durometer Scoring

  Cross-sectional study, 1 visit, <1 hr

• Linear Relationship Between Ultrasound Skin Stiffness and Durometer

  Cross-sectional study, 1 visit, <1 hr

• Mean Landmark Scores

  Cross-sectional study, 1 visit, <1 hr

• Linear Relationship Between Ultrasound Skin Stiffness and Landmark

  Cross-sectional study, 1 visit, <1 hr

• MRSS Scores for Scleroderma Participants.

  Cross-sectional study, 1 visit, <1 hr

Study Arms (2)

ARFI-SVI Ultrasound

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

Device: ARFI-SVI Ultrasound

Healthy Volunteers: ARFI/SVI Ultrasound

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

Device: ARFI-SVI Ultrasound

Interventions

ARFI-SVI Ultrasound 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.

ARFI-SVI Ultrasound; Healthy Volunteers: ARFI/SVI Ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• years of age or older
• Rheumatologic disease of the skin including: Limited Scleroderma, Diffuse Scleroderma, or Eosinophilic Fascitis (Schulman's Syndrome)

You may not qualify if:

• \. None

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Scleroderma, Diffuse

Condition Hierarchy (Ancestors)

Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Results Point of Contact

• Title: Dinesh Khanna
• Organization: University of Michigan

khannad@umich.edu

734-763-7182

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 26, 2013
• First Posted: December 10, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 5, 2019
• Results First Posted: July 5, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)