Compression Device Safety Study

Convatec

Status and phase: Completed; Phase 2

Conditions: Venous Insufficiency

Treatments: Device: Placebo - No device worn; Device: Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs

Study type: Interventional

Funder types: Industry

Identifiers

NCT00732823

CW-0500-05-U337

Details and patient eligibility

About

To evaluate the safety of the Compression Device to subjects with venous insufficiency and oedema.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 4 patient groups, including a placebo group

Profile A

Placebo Comparator group

Description:

No device worn

Treatment:

Device: Placebo - No device worn

Profile B

Active Comparator group

Description:

Foot 40 mmHg, ankle 40 mmHg, mid-calf 35 mmHg, upper calf 30 mmHg

Treatment:

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

Profile C

Active Comparator group

Description:

Foot 50 mmHg, ankle 50 mmHg, mid-calf 45 mmHg, upper calf 40 mmHg

Treatment:

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

Profile D

Active Comparator group

Description:

Foot 60 mmHg, ankle 60 mmHg, mid-calf 55 mmHg, upper calf 50 mmHg

Treatment:

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