Compression Device Safety Study on Edema

Edema Clinical Trial

Official title:

A Phase II Non-Comparative Study Evaluating the Effects of the Compression Test Device on Oedema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00732719
• Other study ID #: CW-0500-04-U332
• Status: Completed
• Phase: Phase 2
• First received: July 23, 2008
• Last updated: October 29, 2008
• Start date: October 2004
• Est. completion date: December 2004

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 prototype Compression Device in subjects with Oedema

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2004
• Est. primary completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

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

• Edema

Intervention

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

• 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

• 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 incidence of adverse events			No
Primary	Volume reduction			No
Primary	Oedema reduction			No