Compression Device Safety Study - Full Text View

Sponsors and Collaborators:	ConvaTec Inc. Bristol-Myers Squibb
Information provided by:	ConvaTec Inc.
ClinicalTrials.gov Identifier:	NCT00732823

Purpose

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

Condition	Intervention	Phase
Venous Insufficiency	Device: Placebo - No device worn Device: Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs	Phase II

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Randomized Study to Evaluate the Safety of the Compression Test Device Using Intermittent Pneumatic Compression Mode in Subjects With Venous Insufficiency and Oedema

Resource links provided by NLM:

MedlinePlus related topics: Edema

Further study details as provided by ConvaTec Inc.:

Primary Outcome Measures:

Secondary Outcome Measures:

Volume reduction will be measured by recording limb volume at the start and end of each profile for both legs. The test leg will be compared to baseline and the contralateral leg. Comfort during wear will be recorded on completion of each profile [ Designated as safety issue: No ]

Enrollment:	16
Study Start Date:	July 2005
Study Completion Date:	October 2005
Primary Completion Date:	October 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Profile A: Placebo Comparator No device worn	Device: Placebo - No device worn
Profile B: Active Comparator Foot 40 mmHg, ankle 40 mmHg, mid-calf 35 mmHg, upper calf 30 mmHg	Device: Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs
Profile C: Active Comparator Foot 50 mmHg, ankle 50 mmHg, mid-calf 45 mmHg, upper calf 40 mmHg	Device: Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs
Profile D: Active Comparator Foot 60 mmHg, ankle 60 mmHg, mid-calf 55 mmHg, upper calf 50 mmHg	Device: Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs

Eligibility

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00732823

Locations

Germany
Hautarzt Phlebologe Allergologe
Freiburg, Germany

Sponsors and Collaborators

ConvaTec Inc.

Bristol-Myers Squibb

Investigators

Principal Investigator:

wolfgang Vanscheidt

Facharzt für Dermatologie Phlebologie Allergologie

More Information

No publications provided

Responsible Party:	Hautarzt Phlebologe Allergologe ( Professor Dr. med Wolfgang Vanscheidt )
Study ID Numbers:	CW-0500-05-U337
Study First Received:	July 23, 2008
Last Updated:	October 29, 2008
ClinicalTrials.gov Identifier:	NCT00732823 History of Changes
Health Authority:	Germany: German Institute of Medical Documentation and Information

Study placed in the following topic categories:

Venous Insufficiency
Vascular Diseases
Edema

Additional relevant MeSH terms:

Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 06, 2009