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Sponsored by: |
Bristol-Myers Squibb |
Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00732719 |
To evaluate the safety of the Compression Device to subject with Oedema
Condition | Intervention | Phase |
Edema |
Device: The battery operated device worn; no pressure given to inflatable cuffs (placebo) Device: A battery operated prototype device based on the use of inflatable pneumatic cuffs |
Phase II |
MedlinePlus related topics: | Edema |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Non-Comparative Study Evaluating the Effects of the Compression Test Device on Oedema |
Enrollment: | 12 |
Study Start Date: | October 2004 |
Study Completion Date: | December 2004 |
Primary Completion Date: | November 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
Profile A: Placebo Comparator
Device worn; no pressure given (placebo)
|
Device: The battery operated device worn; no pressure given to inflatable cuffs (placebo) |
Profile B: Active Comparator
Foot at 30mm Hg, Gaiter at 40 mm Hg, mid-calf at 30 mm Hg and upper cuff at 20mm Hg
|
Device: A battery operated prototype device based on the use of inflatable pneumatic cuffs |
Profile C: Active Comparator
Foot at 20mm Hg, Gaiter at 30 mm Hg, mid-calf at 20 mm Hg and upper cuff at 10mm Hg
|
Device: A battery operated prototype device based on the use of inflatable pneumatic cuffs |
Profile D: Active Comparator
Foot at 10mm Hg, Gaiter at 20 mm Hg, mid-calf at 10 mm Hg and upper cuff at 0mm Hg
|
Device: A battery operated prototype device based on the use of inflatable pneumatic cuffs |
Profile E: Active Comparator
Foot at 30mm Hg, Gaiter at 40 mm Hg, mid-calf at 40 mm Hg and upper cuff at 40mm Hg
|
Device: A battery operated prototype device based on the use of inflatable pneumatic cuffs |
Profile F: Active Comparator
Foot at 20mm Hg, Gaiter at 30 mm Hg, mid-calf at 30 mm Hg and upper cuff at 30mm Hg
|
Device: A battery operated prototype device based on the use of inflatable pneumatic cuffs |
Profile G: Active Comparator
Foot at 10mm Hg, Gaiter at 20 mm Hg, mid-calf at 20 mm Hg and upper cuff at 20mm Hg
|
Device: A battery operated prototype device based on the use of inflatable pneumatic cuffs |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Hautarzt Phlebologe Allergologe ( Professor Wolfgang Vanscheidt ) |
Study ID Numbers: | CW-0500-04-U332 |
First Received: | July 23, 2008 |
Last Updated: | August 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00732719 |
Health Authority: | Germany: German Institute of Medical Documentation and Information |
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