Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Compression Device Safety Study on Edema

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00732719
Recruitment Status : Completed
First Posted : August 12, 2008
Last Update Posted : October 31, 2008
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
ConvaTec Inc.

Tracking Information
First Submitted Date  ICMJE July 23, 2008
First Posted Date  ICMJE August 12, 2008
Last Update Posted Date October 31, 2008
Study Start Date  ICMJE October 2004
Actual Primary Completion Date November 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2008)
  • The nature and incidence of adverse events
  • Volume reduction
  • Oedema reduction
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Compression Device Safety Study on Edema
Official Title  ICMJE A Phase II Non-Comparative Study Evaluating the Effects of the Compression Test Device on Oedema
Brief Summary To evaluate the safety of the prototype Compression Device in subjects with Oedema
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Edema
Intervention  ICMJE
  • Device: Prototype device (unnamed) worn-no pressure given (placebo) from inflatable cuffs
  • Device: Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs
Study Arms  ICMJE
  • Placebo Comparator: Profile A
    Device worn; no pressure given (placebo)
    Intervention: 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
    Intervention: 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
    Intervention: 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
    Intervention: 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
    Intervention: 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
    Intervention: 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
    Intervention: Device: Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 11, 2008)
12
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2004
Actual Primary Completion Date November 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00732719
Other Study ID Numbers  ICMJE CW-0500-04-U332
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Professor Wolfgang Vanscheidt, Hautarzt Phlebologe Allergologe
Study Sponsor  ICMJE ConvaTec Inc.
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE
Principal Investigator: Wolfgang Vanscheidt Hautarzt Phlebologe Allergologe
PRS Account ConvaTec Inc.
Verification Date August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP