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| Name | Class |
|---|---|
| proDERM GmbH | INDUSTRY |
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Fit of made-to-measure compression garments in healthy subjects will be tested on one day, simulating daily activities.
Lower extremities of 36 healthy subjects will be measured by trained experts to collect measures for made-to-measure compression garments.
Fit of made-to-measure compression garments, which are not on the market yet, among healthy subjects will be tested on one day, simulating daily activities. Fit will be assessed directly after donning and after a wearing period of maximum 7 hours at the study site by trained experts. Healthy subjects will give back study products at the end of the wearing period. AEs will be documented throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fit test of made-to-measure garments | Experimental | Healthy subjects will test made-to-measure compression garments |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Made-to-measure compression garment | Device | Subjects will wear one of two made-to-measure compression garments: (1) JOBST® Confidence leggins (BT) and (2) JOBST® Confidence Bermuda (ET) |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the fit of the investigational device | Evaluation of the fit of the investigational medical device at the end of a wearing period of approximately 4 - 7 hours, to be worn by healthy subjects once. The fit will be evaluated visually as well as manually by predefined criteria, e.g. fit of the upper hem, fit of the investigational medical device at the body area, fit at the thighs, fit in the knee area, fit at the lower hem. The fit will be evaluated using a Visual Analog Scale VAS-10 (0=very good to 10= worse). | One day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kirstin Deuble-Bente, Dr. | proDERM GmbH Institut für Angewandte Dermatologische Forschung | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| proDERM GmbH Institut für Angewandte Dermatologische Forschung | Schenefeld | Schleswig-Holstein | 22869 | Germany |
No IPD will be shared. Data are needed for confidential medical device development.
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Healthy subjects will test made-to-measure compression garments. No comparator group due to explorative design.
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