Suction Based Characterization of Healthy and Diseased Skin
NCT ID: NCT03644225
Last Updated: 2023-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
67 participants
INTERVENTIONAL
2018-06-11
2019-06-04
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
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.
OTHER
NONE
Study Groups
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Healthy Control
Healthy controls, who signed an informed consent, age ≥18 years old will be age and sex matched to the SSc patients
Measurment with Aspirational Medical Device
The mechanical properties of healthy and SSc-diseased skin will be assessed by suction based measurements with a new developed Aspirational Medical Device.
Measurment with Cutometer MPA 580
The mechanical properties of healthy and SSc-diseased skin will be assessed by CE-marked Cutometer MPA 580
Systemic sclerosis patients
SSc patients who signed an Informed consent
* Age ≥18 years old
* Diagnosis of systemic sclerosis according to the ACR/EULAR 2013 criteria
* Skin thickening diagnosed by clinical expert
Measurment with Aspirational Medical Device
The mechanical properties of healthy and SSc-diseased skin will be assessed by suction based measurements with a new developed Aspirational Medical Device.
Measurment with Cutometer MPA 580
The mechanical properties of healthy and SSc-diseased skin will be assessed by CE-marked Cutometer MPA 580
Interventions
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Measurment with Aspirational Medical Device
The mechanical properties of healthy and SSc-diseased skin will be assessed by suction based measurements with a new developed Aspirational Medical Device.
Measurment with Cutometer MPA 580
The mechanical properties of healthy and SSc-diseased skin will be assessed by CE-marked Cutometer MPA 580
Eligibility Criteria
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Inclusion Criteria
Healthy volunteers:
\- Age ≥18 years old
SSc-Patients:
* Age ≥18 years old
* Diagnosis of systemic sclerosis according to the ACR/EULAR 2013 criteria
* Skin thickening diagnosed by clinical expert
Exclusion Criteria
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
* Previous enrolment into the current study,
* Participants, who are unable to hold still
* Impaired skin at the regions of measurements
18 Years
65 Years
ALL
Yes
Sponsors
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Swiss Federal Institute of Technology
OTHER
Oliver Distler
OTHER
Responsible Party
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Oliver Distler
Prof.Dr.med.Oliver Distler, Director of the Department of Rhumatology, University Hospital Zurich
Principal Investigators
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Oliver Distler, Prof.Dr.med
Role: PRINCIPAL_INVESTIGATOR
Department of Rheumatology
Locations
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Department of Rheumatology, University Hospital Zurich
Zurich, , Switzerland
Countries
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References
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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.
Other Identifiers
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2017-01154
Identifier Type: OTHER
Identifier Source: secondary_id
Swissmedic:2017-MD_0045
Identifier Type: -
Identifier Source: org_study_id
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