A Pressure Relted Study Comparing a Compression Device and Profore® on Healthy Volunteers

Study Overview
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Brief Summary
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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).

Official Title
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A Phase I, Randomized, Open-label, One-arm, Active Controlled Study to Evaluate the Pressure Interface Between Device and Skin of a Compression Device and Profore® on Healthy Volunteers

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Device: Compression Device
* Device: Profore®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: over 18 years, willing and able to provide written informed consent. able to wear the compression device and Profore® and follow the requirements of the clinical investigation plan an ankle to brachial pressure index (ABPI) of 0.9 or greater CEAP classification C0-C2 healthy volunteers 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: Ankle - 12cm to 44cm Calf - 22cm to 60cm Below knee - 22cm to 68cm

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Compression 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: Immediately following device application 1 hour 4 hours 8 hours|
|Device: Profore®|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |