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

NCT00821808 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2015-10-14

No results posted yet for this study

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

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

Sponsors & Collaborators

  • ConvaTec Inc.

    lead INDUSTRY

Principal Investigators

  • Wolfgang Vanscheidt, MD · Hautarzt Phlebologe Allergologe

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2008-06-30
Completion
2008-06-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00821808 on ClinicalTrials.gov