Scleroderma
Conditions
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.
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.
Interventions
DEVICEARFI-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.
Sponsors
University of Michigan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Exclusion criteria
1\. None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Skin Stiffness | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Linear Relationship Between Ultrasound Skin Stiffness and Durometer | Cross-sectional study, 1 visit, <1 hr | 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. |
| Mean Landmark Scores | Cross-sectional study, 1 visit, <1 hr | Mean Landmark scores are on a scale of 0 to 3, 0 = normal and 3 =marked skin hardening. |
| Mean Skin Stiffness as Measured by Durometer Scoring | Cross-sectional study, 1 visit, <1 hr | 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. |
| MRSS Scores for Scleroderma Participants. | Cross-sectional study, 1 visit, <1 hr | 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. |
| Linear Relationship Between Ultrasound Skin Stiffness and MRSS | Cross-sectional study, 1 visit, <1 hr | 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. |
| Linear Relationship Between Ultrasound Skin Stiffness and Landmark | Cross-sectional study, 1 visit, <1 hr | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Scleroderma Ultrasound imaging of forearm and thigh, lasting approximately 5-10 minutes.
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. | 24 |
| Control Ultrasound imaging of forearm and thigh, lasting approximately 5-10 minutes.
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. | 21 |
| Total | 45 |
Baseline characteristics
| Characteristic | Scleroderma | Control | Total |
|---|---|---|---|
| Age, Continuous | 48.7 years STANDARD_DEVIATION 14.6 | 47.7 years STANDARD_DEVIATION 14.68 | 48.2 years STANDARD_DEVIATION 14.65 |
| Sex: Female, Male Female | 17 Participants | 16 Participants | 33 Participants |
| Sex: Female, Male Male | 7 Participants | 5 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 21 |
| other Total, other adverse events | 0 / 24 | 0 / 21 |
| serious Total, serious adverse events | 0 / 24 | 0 / 21 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Scleroderma | Mean Skin Stiffness | Forearm | 2.68 meters per second | Standard Deviation 0.82 |
| Scleroderma | Mean Skin Stiffness | Thigh | 2.23 meters per second | Standard Deviation 0.48 |
| Control | Mean Skin Stiffness | Forearm | 2.07 meters per second | Standard Deviation 0.25 |
| Control | Mean Skin Stiffness | Thigh | 2.27 meters per second | Standard Deviation 0.36 |
Comparison: This is the p value for the mean skin thickness of the forearm.p-value: 0.005t-test, 2 sided
Comparison: This is the p value for the mean skin stiffness of the thighp-value: 0.71t-test, 2 sided
Secondary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Scleroderma | Linear Relationship Between Ultrasound Skin Stiffness and Durometer | Forearm | 0.45 Correlation coefficient |
| Scleroderma | Linear Relationship Between Ultrasound Skin Stiffness and Durometer | Thigh | 0.40 Correlation coefficient |
Comparison: This is the p value for the forearm.p-value: 0.002Pearson correlation
Comparison: This is the p value for the thighp-value: 0.007Pearson correlation
Secondary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Scleroderma | Linear Relationship Between Ultrasound Skin Stiffness and Landmark | Forearm | .65 correlation coefficient |
| Scleroderma | Linear Relationship Between Ultrasound Skin Stiffness and Landmark | Thigh | .55 correlation coefficient |
Comparison: This is the p-value for the forearmp-value: <0.0001Pearson correlation
Comparison: This is the p-value for the thighp-value: <0.0001Pearson correlation
Secondary
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
Population: Data for 2 of 24 participants is not available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Scleroderma | Linear Relationship Between Ultrasound Skin Stiffness and MRSS | Forearm | 0.53 correlation coefficient |
| Scleroderma | Linear Relationship Between Ultrasound Skin Stiffness and MRSS | Thigh | 0.36 correlation coefficient |
Comparison: This is the p-value for the forearmp-value: 0.01Pearson correlation
Comparison: This is the p-value for the thighp-value: 0.1Pearson correlation
Secondary
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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Scleroderma | Mean Landmark Scores | Forearm | 0.6667 units on a scale |
| Scleroderma | Mean Landmark Scores | Thigh | 0.58333 units on a scale |
| Control | Mean Landmark Scores | Forearm | 0 units on a scale |
| Control | Mean Landmark Scores | Thigh | 0 units on a scale |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Scleroderma | Mean Skin Stiffness as Measured by Durometer Scoring | Forearm | 30.5 units on a scale | Standard Deviation 9.4 |
| Scleroderma | Mean Skin Stiffness as Measured by Durometer Scoring | Thigh | 30.1 units on a scale | Standard Deviation 8.5 |
| Control | Mean Skin Stiffness as Measured by Durometer Scoring | Forearm | 19.1 units on a scale | Standard Deviation 2.8 |
| Control | Mean Skin Stiffness as Measured by Durometer Scoring | Thigh | 19.3 units on a scale | Standard Deviation 3.5 |
Comparison: This is the p-value for the forearmp-value: 0.002Pearson correlation
Comparison: This is the p-value for the thighp-value: 0.007Pearson correlation
Secondary
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
Population: Of 24 scleroderma participants, data was not available for 2.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Scleroderma | MRSS Scores for Scleroderma Participants. | 11.27273 units on a scale |