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

Healthy Volunteers Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00821808
• Other study ID #: CW-0500-08-U347
• Status: Completed
• Phase: Phase 1
• First received: January 13, 2009
• Last updated: October 12, 2015
• Start date: May 2008
• Est. completion date: June 2008

Study information

• Verified date: October 2015
• Source: ConvaTec Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Device:
• 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
• 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

Locations

Country	Name	City	State
Germany	Hautarzt Phlebologe Allergologe	Freiburg

Sponsors (1)

Lead Sponsor	Collaborator
ConvaTec Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the amount of pressure and the variability of interface pressure of the two devices on application		3 days	No
Primary	To evaluate pressure change of the interface pressure with the compression device and Profore® over time		3 days	No
Primary	Safety will be evaluated by the nature and frequency of adverse events.		3 days	No