Compression Device Safety Study on Edema

Study Overview
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Brief Summary
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To evaluate the safety of the prototype Compression Device in subjects with Oedema

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

Conditions
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Edema

Intervention / Treatment
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* Device: Prototype device (unnamed) worn-no pressure given (placebo) from inflatable cuffs
* Device: Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs
* Device: Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs
* Device: Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs
* Device: Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs
* Device: Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs
* Device: Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Profile A<br>Device worn; no pressure given (placebo) | Device: Prototype device (unnamed) worn-no pressure given (placebo) from inflatable cuffs<br> <br> |
| Active Comparator: Profile B<br>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<br> <br> |
| Active Comparator: Profile C<br>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<br> <br> |
| Active Comparator: Profile D<br>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<br> <br> |
| Active Comparator: Profile E<br>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<br> <br> |
| Active Comparator: Profile F<br>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<br> <br> |
| Active Comparator: Profile G<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The nature and incidence of adverse events |  |  | 
| Volume reduction |  |  | 
| Oedema reduction |  |  |