N/A
N=45
Scleroderma ARFI Imaging of the Skin
Scleroderma
Bottom Line
View on ClinicalTrials.gov: NCT02006420 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Mean Skin Stiffness — 2.68; 2.07; 2.23; 2.27 meters per second — p=0.005
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- ARFI-SVI Ultrasound (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Skin Stiffness |
2.68; 2.07; 2.23; 2.27 | 0.005 sig |
| SECONDARY Mean Skin Stiffness as Measured by Durometer Scoring |
30.5; 19.1; 30.1; 19.3 | 0.002 sig |
| SECONDARY Linear Relationship Between Ultrasound Skin Stiffness and Durometer |
0.45; 0.40 | 0.002 sig |
| SECONDARY Mean Landmark Scores |
0.6667; 0; 0.58333; 0 | — |
| SECONDARY Linear Relationship Between Ultrasound Skin Stiffness and Landmark |
.65; .55 | <.0001 sig |
| SECONDARY MRSS Scores for Scleroderma Participants. |
11.27273 | — |
| SECONDARY Linear Relationship Between Ultrasound Skin Stiffness and MRSS |
0.53; 0.36 | 0.01 sig |
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.
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older
- Rheumatologic disease of the skin including: Limited Scleroderma, Diffuse Scleroderma, or Eosinophilic Fascitis (Schulman's Syndrome)
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT02006420). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.