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

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ClinicalTrials.gov Identifier: NCT00821808
Recruitment Status : Completed
First Posted : January 14, 2009
Last Update Posted : October 14, 2015
Sponsor:
Information provided by (Responsible Party):
ConvaTec Inc.

Brief 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).

Condition or disease Intervention/treatment Phase
Healthy Volunteers Device: Compression Device Device: Profore® Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2008
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Intervention Details:
  • 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


Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00821808


Locations
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Germany
Hautarzt Phlebologe Allergologe
Freiburg, Germany
Sponsors and Collaborators
ConvaTec Inc.
Investigators
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Principal Investigator: Wolfgang Vanscheidt, MD Hautarzt Phlebologe Allergologe
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Responsible Party: ConvaTec Inc.
ClinicalTrials.gov Identifier: NCT00821808    
Other Study ID Numbers: CW-0500-08-U347
First Posted: January 14, 2009    Key Record Dates
Last Update Posted: October 14, 2015
Last Verified: October 2015