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Compression Device Safety Study on Edema

Primary Purpose

Edema

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

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

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

About this trial

This is an interventional basic science trial for Edema

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hautarzt Phlebologe Allergologe

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Profile A

Profile B

Profile C

Profile D

Profile E

Profile F

Profile G

Arm Description

Device worn; no pressure given (placebo)

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

The nature and incidence of adverse events

Volume reduction

Oedema reduction

Secondary Outcome Measures

Full Information

NCT ID

NCT00732719

First Posted

July 23, 2008

Last Updated

October 29, 2008

Sponsor

ConvaTec Inc.

Collaborators

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT00732719

Brief Title

Compression Device Safety Study on Edema

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2008

Overall Recruitment Status

Completed

Study Start Date

October 2004 (undefined)

Primary Completion Date

November 2004 (Actual)

Study Completion Date

December 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

ConvaTec Inc.

Collaborators

Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Edema

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Profile A

Arm Type

Placebo Comparator

Arm Description

Device worn; no pressure given (placebo)

Arm Title

Profile B

Arm Type

Active Comparator

Arm Description

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

Arm Title

Profile C

Arm Type

Active Comparator

Arm Description

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

Arm Title

Profile D

Arm Type

Active Comparator

Arm Description

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

Arm Title

Profile E

Arm Type

Active Comparator

Arm Description

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

Arm Title

Profile F

Arm Type

Active Comparator

Arm Description

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

Arm Title

Profile G

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

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

Intervention Type

Device

Intervention Name(s)

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

Intervention Type

Device

Intervention Name(s)

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

Intervention Type

Device

Intervention Name(s)

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

Intervention Type

Device

Intervention Name(s)

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

Intervention Type

Device

Intervention Name(s)

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

Intervention Type

Device

Intervention Name(s)

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

Primary Outcome Measure Information:

Title

The nature and incidence of adverse events

Title

Volume reduction

Title

Oedema reduction

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wolfgang Vanscheidt

Organizational Affiliation

Hautarzt Phlebologe Allergologe

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hautarzt Phlebologe Allergologe

City

Freiburg

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

Compression Device Safety Study on Edema

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