Compression Device Safety Study

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

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

Study Overview

• Status: Completed
• Conditions: Venous Insufficiency
• Intervention / Treatment: Device: Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs; Device: Placebo - No device worn

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Freiburg, Germany
    • Hautarzt Phlebologe Allergologe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The nature and frequency of adverse events
Distal arterial flow

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

• Sponsor: ConvaTec Inc.
• Collaborators: Bristol-Myers Squibb
• Investigators: Principal Investigator: wolfgang Vanscheidt, Facharzt für Dermatologie Phlebologie Allergologie

Study record dates

Study Major Dates

• Study Start: July 1, 2005
• Primary Completion (Actual): October 1, 2005
• Study Completion (Actual): October 1, 2005

Study Registration Dates

• First Submitted: July 23, 2008
• First Submitted That Met QC Criteria: August 11, 2008
• First Posted (Estimate): August 12, 2008

Study Record Updates

• Last Update Posted (Estimate): October 31, 2008
• Last Update Submitted That Met QC Criteria: October 29, 2008
• Last Verified: August 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Venous Insufficiency
• Other Study ID Numbers: CW-0500-05-U337