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Compression Device Safety Study

Primary Purpose

Venous Insufficiency

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Placebo - No device worn
Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs
Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs
Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs
Sponsored by
ConvaTec Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Venous Insufficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hautarzt Phlebologe Allergologe

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Profile A

Profile B

Profile C

Profile D

Arm Description

No device worn

Foot 40 mmHg, ankle 40 mmHg, mid-calf 35 mmHg, upper calf 30 mmHg

Foot 50 mmHg, ankle 50 mmHg, mid-calf 45 mmHg, upper calf 40 mmHg

Foot 60 mmHg, ankle 60 mmHg, mid-calf 55 mmHg, upper calf 50 mmHg

Outcomes

Primary Outcome Measures

The nature and frequency of adverse events
Distal arterial flow

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

Full Information

First Posted
July 23, 2008
Last Updated
October 29, 2008
Sponsor
ConvaTec Inc.
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00732823
Brief Title
Compression Device Safety 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
October 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
ConvaTec Inc.
Collaborators
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Insufficiency

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Profile A
Arm Type
Placebo Comparator
Arm Description
No device worn
Arm Title
Profile B
Arm Type
Active Comparator
Arm Description
Foot 40 mmHg, ankle 40 mmHg, mid-calf 35 mmHg, upper calf 30 mmHg
Arm Title
Profile C
Arm Type
Active Comparator
Arm Description
Foot 50 mmHg, ankle 50 mmHg, mid-calf 45 mmHg, upper calf 40 mmHg
Arm Title
Profile D
Arm Type
Active Comparator
Arm Description
Foot 60 mmHg, ankle 60 mmHg, mid-calf 55 mmHg, upper calf 50 mmHg
Intervention Type
Device
Intervention Name(s)
Placebo - No device worn
Intervention Type
Device
Intervention Name(s)
Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs
Intervention Type
Device
Intervention Name(s)
Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs
Intervention Type
Device
Intervention Name(s)
Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs
Primary Outcome Measure Information:
Title
The nature and frequency of adverse events
Title
Distal arterial flow
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
wolfgang Vanscheidt
Organizational Affiliation
Facharzt für Dermatologie Phlebologie Allergologie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hautarzt Phlebologe Allergologe
City
Freiburg
Country
Germany

12. IPD Sharing Statement

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Compression Device Safety Study

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