Edema
Conditions
Brief summary
To evaluate the safety of the prototype Compression Device in subjects with Oedema
Interventions
DEVICEPrototype device (unnamed) worn-no pressure given (placebo) from inflatable cuffs
Sponsors
Bristol-Myers Squibb
ConvaTec Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The nature and incidence of adverse events | — |
| Volume reduction | — |
| Oedema reduction | — |
Countries
Germany
Outcome results
None listed