SclerodermaARFINCT02006420
Scleroderma ARFI Imaging of the Skin
An observational study of Scleroderma, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Scleroderma
- What is being tested?
- ARFI-SVI Ultrasound
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Dec 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects are people aged 18 or over who are either healthy or who have scleroderma or another rheumatological condition.
Who may be able to join
- 18 years of age or older
- Rheumatologic disease of the skin including: Limited Scleroderma, Diffuse Scleroderma, or Eosinophilic Fascitis (Schulman's Syndrome)
Who cannot join
- 1. None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Hospital
Ann Arbor, Michigan, 48109
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Scleroderma
- Being tested
- ARFI-SVI Ultrasound
- Medical subject headings
- Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARFI-SVI UltrasoundDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| ARFI-SVI Ultrasound | Ultrasound imaging of forearm and thigh, lasting approximately 5-10 minutes. Receives: Device: ARFI-SVI Ultrasound | |
| Healthy Volunteers: ARFI/SVI Ultrasound | Ultrasound imaging of forearm and thigh, lasting approximately 5-10 minutes. Receives: Device: ARFI-SVI Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Cross-sectional study, 1 visit, <1 hr
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Cross-sectional study, 1 visit, <1 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SclerodermaStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dinesh Khanna, MD, MS, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02006420
- Sponsor's protocol ID
- HUM00074229
- Acronym
- ARFI
- Status last verified
- Apr 2019
- First submitted
- 26 Nov 2013
- Last updated
- 5 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acoustic Radiation Force Impulse/Shear Wave Velocity Imaging of the Skin in Scleroderma and Other Rheumatologic Diseases
- ClinicalTrials.gov ID
- NCT02006420
- Acronym / sponsor ID
- ARFI / HUM00074229
- Conditions
- Scleroderma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 10 Dec 2013 (estimated)
- Results
- Posted 5 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARFI-SVI Ultrasound | – | Device: ARFI-SVI UltrasoundUltrasound imaging of forearm and thigh, lasting approximately 5-10 minutes. |
| Healthy Volunteers: ARFI/SVI Ultrasound | – | Device: ARFI-SVI UltrasoundUltrasound imaging of forearm and thigh, lasting approximately 5-10 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects are people aged 18 or over who are either healthy or who have scleroderma or another rheumatological condition.
Key inclusion criteria (2 listed)
- 18 years of age or older
- Rheumatologic disease of the skin including: Limited Scleroderma, Diffuse Scleroderma, or Eosinophilic Fascitis (Schulman's Syndrome)
Key exclusion criteria (1 listed)
- 1. None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARFI-SVI UltrasoundUltrasound 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. | Device | ARFI-SVI Ultrasound, Healthy Volunteers: ARFI/SVI Ultrasound |
Primary outcome
Mean Skin Stiffness
Time frame: 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).
6 secondary outcomes
Mean Skin Stiffness as Measured by Durometer Scoring
Time frame: Cross-sectional study, 1 visit, <1 hr
Linear Relationship Between Ultrasound Skin Stiffness and Durometer
Time frame: Cross-sectional study, 1 visit, <1 hr
Mean Landmark Scores
Time frame: Cross-sectional study, 1 visit, <1 hr
Linear Relationship Between Ultrasound Skin Stiffness and Landmark
Time frame: Cross-sectional study, 1 visit, <1 hr
MRSS Scores for Scleroderma Participants.
Time frame: Cross-sectional study, 1 visit, <1 hr
Linear Relationship Between Ultrasound Skin Stiffness and MRSS
Time frame: Cross-sectional study, 1 visit, <1 hr
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scleroderma, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Skin Stiffness (time frame: Cross-sectional study, 1 visit, <1 hr). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.