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).

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Device: Compression Device; Device: Profore®

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Freiburg, Germany
    • Hautarzt Phlebologe Allergologe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: ConvaTec Inc.
• Investigators: Principal Investigator: Wolfgang Vanscheidt, MD, Hautarzt Phlebologe Allergologe

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: January 13, 2009
• First Submitted That Met QC Criteria: January 13, 2009
• First Posted (Estimate): January 14, 2009

Study Record Updates

• Last Update Posted (Estimate): October 14, 2015
• Last Update Submitted That Met QC Criteria: October 12, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: CW-0500-08-U347