This phase I Healthy Volunteer study will evaluate the pressure interface between the devices (a compression device and Profore®) and the skin, using the PicoPress(TM) pressure transducer at specified time intervals in three distinct locations on the leg, in both the sitting and standing position. It will also assess the variability of interface pressure following application under each test device for each subject over a period of three days (three separate applications).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
The compression device will be worn for 8 hours each day on one leg. The device will be applied by the same clinician every morning.Interface pressure measurements will be made in both the sitting and standing position at three locations on the leg at the following time intervals: * Immediately following device application * 1 hour * 4 hours * 8 hours
Profore® will be worn for 8 hours each day on opposite leg. Profore® will be applied by the same clinician every morning.Interface pressure measurements will be made in both the sitting and standing position at three locations on the leg at the following time intervals: * Immediately following device application * 1 hour * 4 hours * 8 hours
Hautarzt Phlebologe Allergologe
Freiburg im Breisgau, Germany
To evaluate the amount of pressure and the variability of interface pressure of the two devices on application
Time frame: 3 days
To evaluate pressure change of the interface pressure with the compression device and Profore® over time
Time frame: 3 days
Safety will be evaluated by the nature and frequency of adverse events.
Time frame: 3 days
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