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

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

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).

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