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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00732719
Other study ID # CW-0500-04-U332
Secondary ID
Status Completed
Phase Phase 2
First received July 23, 2008
Last updated October 29, 2008
Start date October 2004
Est. completion date December 2004

Study information

Verified date August 2008
Source ConvaTec Inc.
Contact n/a
Is FDA regulated No
Health authority Germany: German Institute of Medical Documentation and Information
Study type Interventional

Clinical Trial Summary

To evaluate the safety of the prototype Compression Device in subjects with Oedema


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date December 2004
Est. primary completion date November 2004
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Subjects aged between 18 and 80, willing and able to provide written informed consent, and able to wear the device and follow the requirements of the protocol

- 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 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Device:
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


Locations

Country Name City State
Germany Hautarzt Phlebologe Allergologe Freiburg

Sponsors (2)

Lead Sponsor Collaborator
ConvaTec Inc. Bristol-Myers Squibb

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary The nature and incidence of adverse events No
Primary Volume reduction No
Primary Oedema reduction No
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