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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-01154 | Other Identifier | Ethikkommission |
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| Name | Class |
|---|---|
| Swiss Federal Institute of Technology | OTHER |
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The mechanical properties of healthy and SSc-diseased skin will be assessed by suction based measurements. The negative pressure needed to gain a certain tissue elevation, tissue elevation in response to a certain negative pressure as well as the time of retraction of tissue will be recorded and analyzed. Mesurments will be done with the new developed Aspiration Device_Nimble and with the CE-certified Cutometer MPA 580.
Patients with systemic sclerosis (SSc) show a thickening of the skin due to massive deposition of collagen and temporary edema in the dermis. The clinical palpation method is currently the only diagnosis method. For an objective detection a non-invasive skin elasticity measurement can be performed. The widely used approach is based on local tissue suction. This study aims at an identification and quantification of mechanical and structural properties of human skin. The results will then be compared in age- and gender matched control groups. For evaluation of the skin elasticity measurement the results will be compared to the clinical parametar validated, modified Rodnan skin score (mRSS).
The mechanical properties of healthy and diseased skin will be assessed by suction based measurements. The negative pressure is needed to gain a certain tissue elevation. Tissue elevation in response to a certain negative pressure as well as the time of retraction of tissue will be recorded and analyzed. (The different parameters depend on
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Control | Other | Healthy controls, who signed an informed consent, age ≥18 years old will be age and sex matched to the SSc patients |
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| Systemic sclerosis patients | Other | SSc patients who signed an Informed consent
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Measurment with Aspirational Medical Device | Device | The mechanical properties of healthy and SSc-diseased skin will be assessed by suction based measurements with a new developed Aspirational Medical Device. |
| Measure | Description | Time Frame |
|---|---|---|
| Mechanical characterization of healthy and diseased skin using novel aspiration device and comparing it to the already validated Cutometer® MPA 580. | The stiffness (mbar/mm) properties of healthy skin and SSc skin will be measured with the Aspiration Device and the Cutometer MPA 580. For comparison of different locations on the body, back of the hand (left and right) and dorsal forearm (left and right) will be assessed for every participant at one time point (Visite 1). | one visit, one measurement, one year |
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Inclusion Criteria:
-Signed Informed Consent
Healthy volunteers:
- Age ≥18 years old
SSc-Patients:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oliver Distler, Prof.Dr.med | Department of Rheumatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Rheumatology, University Hospital Zurich | Zurich | 8091 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32493508 | Derived | Muller B, Ruby L, Jordan S, Rominger MB, Mazza E, Distler O. Validation of the suction device Nimble for the assessment of skin fibrosis in systemic sclerosis. Arthritis Res Ther. 2020 Jun 3;22(1):128. doi: 10.1186/s13075-020-02214-y. |
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| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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Primary outcome:
Mechanical characterization of healthy and diseased skin using novel aspiration device and comparing it to the already validated Cutometer® MPA 580. Comparison of mechanical skin properties of healthy to patients' skin tissue (control vs. examined group).
Secondary outcome:
Defining predictors of the skin worsening.
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No randomisation
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| Measurment with Cutometer MPA 580 | Device | The mechanical properties of healthy and SSc-diseased skin will be assessed by CE-marked Cutometer MPA 580 |
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