NCT00821808

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: ConvaTec Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2008-05-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2009-01-14
• Last updated: 2015-10-14

Locations

1 site across 1 country: Germany