Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
12 participants
INTERVENTIONAL
2004-10-31
2004-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Profile A
Device worn; no pressure given (placebo)
Prototype device (unnamed) worn-no pressure given (placebo) from inflatable cuffs
Profile B
Foot at 30mm Hg, Gaiter at 40 mm Hg, mid-calf at 30 mm Hg and upper cuff at 20mm Hg
Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs
Profile C
Foot at 20mm Hg, Gaiter at 30 mm Hg, mid-calf at 20 mm Hg and upper cuff at 10mm Hg
Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs
Profile D
Foot at 10mm Hg, Gaiter at 20 mm Hg, mid-calf at 10 mm Hg and upper cuff at 0mm Hg
Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs
Profile E
Foot at 30mm Hg, Gaiter at 40 mm Hg, mid-calf at 40 mm Hg and upper cuff at 40mm Hg
Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs
Profile F
Foot at 20mm Hg, Gaiter at 30 mm Hg, mid-calf at 30 mm Hg and upper cuff at 30mm Hg
Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs
Profile G
Foot at 10mm Hg, Gaiter at 20 mm Hg, mid-calf at 20 mm Hg and upper cuff at 20mm Hg
Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs
Interventions
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Prototype device (unnamed) worn-no pressure given (placebo) from inflatable cuffs
Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs
Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs
Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs
Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs
Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs
Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs
Eligibility Criteria
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Inclusion Criteria
* Subjects who have an ankle to brachial pressure index (ABPI) of at least 0.8.
* Subjects who suffer from chronic oedema (i.e. CEAP classification of C3, C4 or C5 1.)
* Subjects who have Chronic Venous Insufficiency (CVI), which has been present for 6 weeks or longer and who have refluxes \>0.5 sec in one or more major venous segments, superficial or deep or both (CEAP classification: C3-C5 1.; Ep,s; As,d; Pr).
Exclusion Criteria
* Subjects who have previously been entered into the study before
* Subjects who have a history of Deep Vein Thrombosis (DVT) within the last 6 months
* Subjects who have an active leg ulcer (i.e. CEAP classification of C6 1).
* Subjects with active cardiac disease or significant history of cardiac disease (including history of myocardial infarction, heart failure, valvular disease, arrhythmia and those with a pacemaker or have previously had a pacemaker).
* Subjects who have initiated treatment or changed the dose within the past month of pharmaceutical agents that reduce clotting e.g. aspirin (except low-dose aspirin), anti-platelets, anti-coagulants and coumarin.
* Subjects who are currently taking pharmaceutical agents that can modify the amount of leg oedema (e.g., diuretics, dihydropyridine calcium channel blockers, phlebotonic drugs, or fluctuating doses of systemic steroids) or have taken these agents within the last 10 days.
* Subjects who are pregnant
* Subjects who have worn compression therapy in the last 48 hours
18 Years
80 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
ConvaTec Inc.
INDUSTRY
Responsible Party
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Hautarzt Phlebologe Allergologe
Principal Investigators
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Wolfgang Vanscheidt
Role: PRINCIPAL_INVESTIGATOR
Hautarzt Phlebologe Allergologe
Locations
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Hautarzt Phlebologe Allergologe
Freiburg im Breisgau, , Germany
Countries
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Other Identifiers
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CW-0500-04-U332
Identifier Type: -
Identifier Source: org_study_id