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Compression Device Safety Study on Edema

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
ConvaTec Inc.
ClinicalTrials.gov Identifier:
NCT00732719
First received: July 23, 2008
Last updated: October 29, 2008
Last verified: August 2008
History of Changes
  Purpose

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


Condition Intervention Phase
Edema
 Device: Prototype device (unnamed) worn-no pressure given (placebo) from inflatable cuffs
Device: Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Phase II Non-Comparative Study Evaluating the Effects of the Compression Test Device on Oedema

Resource links provided by NLM:

MedlinePlus related topics: Edema
U.S. FDA Resources

Further study details as provided by ConvaTec Inc.:

Primary Outcome Measures:
  • The nature and incidence of adverse events [ Designated as safety issue: No ]
  • Volume reduction [ Designated as safety issue: No ]
  • Oedema reduction [ Designated as safety issue: No ]

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
Placebo Comparator: Profile A
Device worn; no pressure given (placebo)
 Device: Prototype device (unnamed) worn-no pressure given (placebo) from inflatable cuffs
Active Comparator: Profile B
Foot at 30mm Hg, Gaiter at 40 mm Hg, mid-calf at 30 mm Hg and upper cuff at 20mm Hg
 Device: Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs
Active Comparator: Profile C
Foot at 20mm Hg, Gaiter at 30 mm Hg, mid-calf at 20 mm Hg and upper cuff at 10mm Hg
 Device: Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs
Active Comparator: Profile D
Foot at 10mm Hg, Gaiter at 20 mm Hg, mid-calf at 10 mm Hg and upper cuff at 0mm Hg
 Device: Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs
Active Comparator: Profile E
Foot at 30mm Hg, Gaiter at 40 mm Hg, mid-calf at 40 mm Hg and upper cuff at 40mm Hg
 Device: Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs
Active Comparator: Profile F
Foot at 20mm Hg, Gaiter at 30 mm Hg, mid-calf at 30 mm Hg and upper cuff at 30mm Hg
 Device: Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs
Active Comparator: Profile G
Foot at 10mm Hg, Gaiter at 20 mm Hg, mid-calf at 20 mm Hg and upper cuff at 20mm Hg
 Device: Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
ConvaTec Inc.
Bristol-Myers Squibb
Investigators
Principal Investigator: Wolfgang Vanscheidt Hautarzt Phlebologe Allergologe
  More Information

No publications provided

Responsible Party: Professor Wolfgang Vanscheidt, Hautarzt Phlebologe Allergologe
ClinicalTrials.gov Identifier: NCT00732719     History of Changes
Other Study ID Numbers: CW-0500-04-U332
Study First Received: July 23, 2008
Last Updated: October 29, 2008
Health Authority: Germany: German Institute of Medical Documentation and Information

Additional relevant MeSH terms:
Edema
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013