Compression Device Safety Study

Venous Insufficiency Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00732823
• Other study ID #: CW-0500-05-U337
• Status: Completed
• Phase: Phase 2
• First received: July 23, 2008
• Last updated: October 29, 2008
• Start date: July 2005
• Est. completion date: October 2005

Study information

• Verified date: August 2008
• Source: ConvaTec Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: German Institute of Medical Documentation and Information
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Venous Insufficiency

Intervention

Device:
• Placebo - No device worn

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

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

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

Locations

Country	Name	City	State
Germany	Hautarzt Phlebologe Allergologe	Freiburg

Sponsors (2)

Lead Sponsor	Collaborator
ConvaTec Inc.	Bristol-Myers Squibb

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The nature and frequency of adverse events			No
Primary	Distal arterial flow			No
Secondary	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			No