Compression Device Safety Study | NCT00732823

Studies
Compression Device Safety Study

NCT00732823

Sponsor

ConvaTec Inc.

Status

Completed

Last Update Posted

Oct 31, 2008Estimated

Enrollment

16Actual

Phase

Phase 2

Conditions

Venous Insufficiency

Interventions

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

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2005

Primary Completion Date

Oct 2005Actual

Completion Date

Oct 2005Actual

First Submitted Date

Jul 23, 2008

First Submission Date that Met QC Criteria

Aug 11, 2008

First Posted Date

Aug 12, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 29, 2008

Last Update Posted Date

Oct 31, 2008Estimated

Name	Class
Bristol-Myers Squibb	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Profile A	Placebo Comparator	No device worn	Device: Placebo - No device worn
Profile B	Active Comparator	Foot 40 mmHg, ankle 40 mmHg, mid-calf 35 mmHg, upper calf 30 mmHg	Device: Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs
Profile C	Active Comparator	Foot 50 mmHg, ankle 50 mmHg, mid-calf 45 mmHg, upper calf 40 mmHg	Device: Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs
Profile D	Active Comparator	Foot 60 mmHg, ankle 60 mmHg, mid-calf 55 mmHg, upper calf 50 mmHg	Device: Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo - No device worn	Device		Profile A
Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs

Measure	Description	Time Frame
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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Measure	Description	Time Frame
The nature and frequency of adverse events
Distal arterial flow