Compression Device Safety Study on Edema - Full Text View

Purpose

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

U.S. FDA Resources

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

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

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

Eligibility

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00732719

Locations


Germany
	Hautarzt Phlebologe Allergologe
	Freiburg, Germany

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators


Principal Investigator:	Wolfgang Vanscheidt	Hautarzt Phlebologe Allergologe

More Information

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

Study placed in the following topic categories:

Signs and Symptoms

Edema

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00732719