Compression Device Safety Study on Edema

A Phase II Non-Comparative Study Evaluating the Effects of the Compression Test Device on Oedema

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

Study Overview

• Status: Completed
• Conditions: Edema
• Intervention / Treatment: Device: Prototype device (unnamed) worn-no pressure given (placebo) from inflatable cuffs; Device: Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Freiburg, Germany
    • Hautarzt Phlebologe Allergologe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The nature and incidence of adverse events
Volume reduction
Oedema reduction

Collaborators and Investigators

• Sponsor: ConvaTec Inc.
• Collaborators: Bristol-Myers Squibb
• Investigators: Principal Investigator: Wolfgang Vanscheidt, Hautarzt Phlebologe Allergologe

Study record dates

Study Major Dates

• Study Start: October 1, 2004
• Primary Completion (ACTUAL): November 1, 2004
• Study Completion (ACTUAL): December 1, 2004

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: Edema
• Other Study ID Numbers: CW-0500-04-U332