Healthy Volunteers
Conditions
Brief summary
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).
Interventions
DEVICECompression 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
DEVICEProfore®
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
Sponsors
ConvaTec Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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 |
Countries
Germany
Outcome results
None listed