Compression Device Safety Study

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

Official Title
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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

Conditions
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Venous Insufficiency

Intervention / Treatment
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* Device: Placebo - No device worn
* 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 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

Ages Eligible for Study
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Minimum Age: 18 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>No device worn | Device: Placebo - No device worn<br> <br> |
| Active Comparator: Profile B<br>Foot 40 mmHg, ankle 40 mmHg, mid-calf 35 mmHg, upper calf 30 mmHg | Device: Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs<br> <br> |
| Active Comparator: Profile C<br>Foot 50 mmHg, ankle 50 mmHg, mid-calf 45 mmHg, upper calf 40 mmHg | Device: Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs<br> <br> |
| Active Comparator: Profile D<br>Foot 60 mmHg, ankle 60 mmHg, mid-calf 55 mmHg, upper calf 50 mmHg | 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 frequency of adverse events |  |  | 
| Distal arterial flow |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  |