Clinical trial NCT00732823: Compression Device Safety Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Venous Insufficiency
Lead sponsor: ConvaTec Inc.
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2008-08-12
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: 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

Primary outcomes:
measure: The nature and frequency of adverse events
measure: Distal arterial flow
Secondary outcomes:
measure: 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
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Hautarzt Phlebologe Allergologe
Study officials:
affiliation: Facharzt für Dermatologie Phlebologie Allergologie
name: wolfgang Vanscheidt
role: PRINCIPAL_INVESTIGATOR
References: