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Compression Device Safety Study

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
ConvaTec Inc.
ClinicalTrials.gov Identifier:
NCT00732823
First received: July 23, 2008
Last updated: October 29, 2008
Last verified: August 2008
History of Changes
  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 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 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
U.S. FDA Resources

Further study details as provided by ConvaTec Inc.:

Primary Outcome Measures:
  • The nature and frequency of adverse events [ Designated as safety issue: No ]
  • Distal arterial flow [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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: Professor Dr. med Wolfgang Vanscheidt, Hautarzt Phlebologe Allergologe
ClinicalTrials.gov Identifier: NCT00732823     History of Changes
Other Study ID Numbers: CW-0500-05-U337
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:
Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013