Compression Device Safety Study on Edema

Phase 2

Completed

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

• Registration Number: NCT00732719
• Lead Sponsor: ConvaTec Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Primary Completion: 2004-11
• Study Completion: 2004-12
• Study First Submitted: 2008-07-23
• Status Verified: 2008-08
• Study First Submitted QC: 2008-08-11
• Study First Posted: 2008-08-12
• Last Update Submitted: 2008-10-29
• Last Update Posted: 2008-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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).

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Profile A	Prototype device (unnamed) worn-no pressure given (placebo) from inflatable cuffs	Device worn; no pressure given (placebo)
Profile B	Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs	Foot at 30mm Hg, Gaiter at 40 mm Hg, mid-calf at 30 mm Hg and upper cuff at 20mm Hg
Profile C	Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs	Foot at 20mm Hg, Gaiter at 30 mm Hg, mid-calf at 20 mm Hg and upper cuff at 10mm Hg
Profile E	Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs	Foot at 30mm Hg, Gaiter at 40 mm Hg, mid-calf at 40 mm Hg and upper cuff at 40mm Hg
Profile F	Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs	Foot at 20mm Hg, Gaiter at 30 mm Hg, mid-calf at 30 mm Hg and upper cuff at 30mm Hg
Profile G	Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs	Foot at 10mm Hg, Gaiter at 20 mm Hg, mid-calf at 20 mm Hg and upper cuff at 20mm Hg
Profile D	Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs	Foot at 10mm Hg, Gaiter at 20 mm Hg, mid-calf at 10 mm Hg and upper cuff at 0mm Hg

Primary Outcome Measures

Name	Time	Method
Volume reduction
Oedema reduction
The nature and incidence of adverse events

Trial Locations

Locations (1)

Hautarzt Phlebologe Allergologe; 🇩🇪 Freiburg, Germany