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

October 12, 2015 updated by: ConvaTec Inc.

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

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Germany
- - Freiburg, Germany
    - Hautarzt Phlebologe Allergologe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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 Time Frame: 3 days	3 days
To evaluate pressure change of the interface pressure with the compression device and Profore® over time Time Frame: 3 days	3 days
Safety will be evaluated by the nature and frequency of adverse events. Time Frame: 3 days	3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ConvaTec Inc.

Investigators

Principal Investigator: Wolfgang Vanscheidt, MD, Hautarzt Phlebologe Allergologe

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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