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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
36
Subjects will wear one of two made-to-measure compression garments: (1) JOBST® Confidence leggins (BT) and (2) JOBST® Confidence Bermuda (ET)
proDERM GmbH Institut für Angewandte Dermatologische Forschung
Schenefeld, Schleswig-Holstein, Germany
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).
Time frame: One day
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