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

Convatec

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Device: Compression Device

Device: Profore®

Study type

Interventional

Funder types

Industry

Identifiers

NCT00821808

CW-0500-08-U347

Details and patient eligibility

About

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).

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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