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

NCT ID: NCT00821808

Last Updated: 2015-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2008-06-30

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).

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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

Intervention Type: 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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ConvaTec Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wolfgang Vanscheidt, MD

Role: PRINCIPAL_INVESTIGATOR

Hautarzt Phlebologe Allergologe

Locations

Hautarzt Phlebologe Allergologe

Freiburg im Breisgau, , Germany

Countries

Germany

Other Identifiers

CW-0500-08-U347

Identifier Type: -

Identifier Source: org_study_id