Compression Device Safety Study on Edema

Convatec

Status and phase

Completed

Phase 2

Conditions

Edema

Treatments

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

Funder types

Industry

Identifiers

NCT00732719

CW-0500-04-U332

Details and patient eligibility

About

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

Enrollment

12 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

12 participants in 7 patient groups, including a placebo group

Profile A

Placebo Comparator group

Description:

Device worn; no pressure given (placebo)

Treatment:

Device: Prototype device (unnamed) worn-no pressure given (placebo) from inflatable cuffs

Profile B

Active Comparator group

Description:

Foot at 30mm Hg, Gaiter at 40 mm Hg, mid-calf at 30 mm Hg and upper cuff at 20mm Hg

Treatment:

Device: Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs

Profile C

Active Comparator group

Description:

Foot at 20mm Hg, Gaiter at 30 mm Hg, mid-calf at 20 mm Hg and upper cuff at 10mm Hg

Treatment:

Device: Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs

Profile D

Active Comparator group

Description:

Foot at 10mm Hg, Gaiter at 20 mm Hg, mid-calf at 10 mm Hg and upper cuff at 0mm Hg

Treatment:

Device: Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs

Profile E

Active Comparator group

Description:

Foot at 30mm Hg, Gaiter at 40 mm Hg, mid-calf at 40 mm Hg and upper cuff at 40mm Hg

Treatment:

Device: Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs

Profile F

Active Comparator group

Description:

Foot at 20mm Hg, Gaiter at 30 mm Hg, mid-calf at 30 mm Hg and upper cuff at 30mm Hg

Treatment:

Device: Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs

Profile G

Active Comparator group

Description:

Foot at 10mm Hg, Gaiter at 20 mm Hg, mid-calf at 20 mm Hg and upper cuff at 20mm Hg

Treatment:

Device: Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs

Trial contacts and locations

Data sourced from clinicaltrials.gov

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