An observational study in Scleroderma, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-05.
Sponsored by University of Michigan · Observational
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.
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.
688 studies on the registry are indexed under Scleroderma, Systemic; 223 are open to participants now.
This study's enrollment of 45 is below the median of 100 across 169 observational studies indexed under Scleroderma, Systemic.
Browse Scleroderma, Systemic studies →University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects are people aged 18 or over who are either healthy or who have scleroderma or another rheumatological condition.
Exclusion Criteria:
Ultrasound imaging of forearm and thigh, lasting approximately 5-10 minutes.
Device: ARFI-SVI Ultrasound
Ultrasound imaging of forearm and thigh, lasting approximately 5-10 minutes.
Device: 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.
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).
Time frame: Cross-sectional study, 1 visit, <1 hr
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Cross-sectional study, 1 visit, <1 hr
| Milestone | Scleroderma | Control |
|---|---|---|
| Started | 24 | 21 |
| Completed | 24 | 21 |
| Not completed | 0 | 0 |
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).
| meters per second | Scleroderma | Control |
|---|---|---|
| Forearm | 2.68 ± 0.82 | 2.07 ± 0.25 |
| Thigh | 2.23 ± 0.48 | 2.27 ± 0.36 |
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.
| units on a scale | Scleroderma | Control Arm |
|---|---|---|
| Forearm | 30.5 ± 9.4 | 19.1 ± 2.8 |
| Thigh | 30.1 ± 8.5 | 19.3 ± 3.5 |
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.
| Correlation coefficient | All Participants |
|---|---|
| Forearm | 0.45 |
| Thigh | 0.40 |
Mean Landmark scores are on a scale of 0 to 3, 0 = normal and 3 =marked skin hardening.
| units on a scale | Scleroderma | Control Arm |
|---|---|---|
| Forearm | 0.6667 (0 to 2) | 0 (0 to 0) |
| Thigh | 0.58333 (0 to 2) | 0 (0 to 0) |
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.
| correlation coefficient | Stiffness vs. Landmark |
|---|---|
| Forearm | .65 |
| Thigh | .55 |
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.
| units on a scale | Scleroderma Participants |
|---|---|
| MRSS Scores for Scleroderma Participants. | 11.27273 (2 to 29) |
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.
| correlation coefficient | Stiffness vs. MRSS |
|---|---|
| Forearm | 0.53 |
| Thigh | 0.36 |
Collected over single visit; less than 1 hour; no specific follow up.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Scleroderma | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
| Control | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
| Age, Continuous(years) | Scleroderma | Control | Total |
|---|---|---|---|
| Mean | 48.7 ± 14.6 | 47.7 ± 14.68 | 48.2 ± 14.65 |
| Sex: Female, Male(Participants) | Scleroderma | Control | Total |
|---|---|---|---|
| Female | 17 | 16 | 33 |
| Male | 7 | 5 | 12 |
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