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Compression Device Safety Study

NCT ID: NCT00732823

Last Updated: 2008-10-31

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2005-10-31

Brief Summary

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To evaluate the safety of the Compression Device to subjects with venous insufficiency and oedema.

Detailed Description

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Conditions

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Venous Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Profile A

No device worn

Group Type PLACEBO_COMPARATOR

Placebo - No device worn

Intervention Type DEVICE

Profile B

Foot 40 mmHg, ankle 40 mmHg, mid-calf 35 mmHg, upper calf 30 mmHg

Group Type ACTIVE_COMPARATOR

Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs

Intervention Type DEVICE

Profile C

Foot 50 mmHg, ankle 50 mmHg, mid-calf 45 mmHg, upper calf 40 mmHg

Group Type ACTIVE_COMPARATOR

Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs

Intervention Type DEVICE

Profile D

Foot 60 mmHg, ankle 60 mmHg, mid-calf 55 mmHg, upper calf 50 mmHg

Group Type ACTIVE_COMPARATOR

Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs

Intervention Type DEVICE

Interventions

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Placebo - No device worn

Intervention Type DEVICE

Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs

Intervention Type DEVICE

Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs

Intervention Type DEVICE

Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subjects over 18 years, willing and able to provide written informed consent.
* Subjects able to wear the Amadeus device and follow the requirements of the clinical investigation plan
* Subjects who have an ankle to brachial pressure index (ABPI) of ABPI \>0.8
* Subjects with chronic lower limb 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 with a history of skin sensitivity to any of the components of the study product.
* 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
* Subjects who have leg sizes outside the following range:

* Ankle 17cm - 32cm
* Calf 27cm - 47cm
* Below Knee 29cm - 51cm
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

ConvaTec Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Hautarzt Phlebologe Allergologe

Principal Investigators

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wolfgang Vanscheidt

Role: PRINCIPAL_INVESTIGATOR

Facharzt für Dermatologie Phlebologie Allergologie

Locations

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Hautarzt Phlebologe Allergologe

Freiburg im Breisgau, , Germany

Site Status

Countries

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Germany

Other Identifiers

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CW-0500-05-U337

Identifier Type: -

Identifier Source: org_study_id