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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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compression Device | Device | 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:
| ||
| Profore® | Device | 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the amount of pressure and the variability of interface pressure of the two devices on application | 3 days | |
| To evaluate pressure change of the interface pressure with the compression device and Profore® over time | 3 days | |
| Safety will be evaluated by the nature and frequency of adverse events. | 3 days |
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Inclusion Criteria:
Exclusion Criteria:
history of skin sensitivity to any of the components of the study product
participated in a previous clinical study within the past 3 months
active Deep Vein Thrombosis (DVT) or a recent DVT within the last 3 months
exhibited any other medical condition which, according to the Investigator, justifies the subject's exclusion from the study
leg sizes outside the following range:
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| Name | Affiliation | Role |
|---|---|---|
| Wolfgang Vanscheidt, MD | Hautarzt Phlebologe Allergologe | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hautarzt Phlebologe Allergologe | Freiburg im Breisgau | Germany |
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| ID | Term |
|---|---|
| D048228 | Intermittent Pneumatic Compression Devices |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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