Skip to main content
OpenTrials
Completed

NCT Number: NCT00821808

A Pressure Relted Study Comparing 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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Volunteers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hautarzt Phlebologe Allergologe

Freiburg im Breisgau, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Compression device

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

Profore®

Device

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

Primary outcomes

  1. To evaluate the amount of pressure and the variability of interface pressure of the two devices on application

    Time frame: 3 days

  2. To evaluate pressure change of the interface pressure with the compression device and Profore® over time

    Time frame: 3 days

  3. Safety will be evaluated by the nature and frequency of adverse events.

    Time frame: 3 days

Sponsors and collaborators

Lead sponsor

ConvaTec Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jan 14, 2009
Registry last updated
Oct 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.