Compression Device Safety Study on Edema

NCT00732719 | Completed Phase 2

• 1 other identifier: CW-0500-04-U332
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Edema

Outcome Measures

Primary Outcomes (3)

• The nature and incidence of adverse events

• Volume reduction

• Oedema reduction

Study Arms (7)

Profile A

PLACEBO COMPARATOR

Device worn; no pressure given (placebo)

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

Profile B

ACTIVE COMPARATOR

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

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

Profile C

ACTIVE COMPARATOR

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

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

Profile D

ACTIVE COMPARATOR

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

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

Profile E

ACTIVE COMPARATOR

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

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

Profile F

ACTIVE COMPARATOR

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

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

Profile G

ACTIVE COMPARATOR

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

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

Interventions

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

Profile A

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

Profile B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• ConvaTec Inc.: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Hautarzt Phlebologe Allergologe

Freiburg im Breisgau, Germany

Location

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wolfgang Vanscheidt

  Hautarzt Phlebologe Allergologe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 23, 2008
• First Posted: August 12, 2008
• Study Start: October 1, 2004
• Primary Completion: November 1, 2004
• Study Completion: December 1, 2004
• Last Updated: October 31, 2008

Record last verified: 2008-08

Locations

DE (1)