Venous InsufficiencyPhase 2NCT00732823
Compression Device Safety Study
A Phase 2 study testing Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs in people with Venous Insufficiency, run by ConvaTec Inc. at 1 site in Germany.
Trial summary
To evaluate the safety of the Compression Device to subjects with venous insufficiency and oedema. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Insufficiency
- What is being tested?
- Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2005to Oct 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
To evaluate the safety of the Compression Device to subjects with venous insufficiency and oedema.
- Conditions
- Venous Insufficiency
- Being tested
- Placebo - No device worn, Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs
- Medical subject headings
- Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo - No device wornDevice
Prototype device(unnamed)-A battery operated inflatable pneumatic cuffsDevice
Prototype device(unnamed)-A battery operated inflatable pneumatic cuffsDevice
Prototype device(unnamed)-A battery operated inflatable pneumatic cuffsDevice
| Study group | Role | What they receive |
|---|---|---|
| Profile A | Placebo comparator | No device worn Receives: Device: Placebo - No device worn |
| Profile B | Active comparator | Foot 40 mmHg, ankle 40 mmHg, mid-calf 35 mmHg, upper calf 30 mmHg Receives: 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 Receives: 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 Receives: Device: Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs |
What is being measured
The primary outcome is the main question the study is designed to answer.
The nature and frequency of adverse events
Distal arterial flow
Secondary outcomes (1)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2008 (estimated)
- Study startJul 2005
- Primary completionOct 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- ConvaTec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Investigators
- wolfgang Vanscheidt, Principal investigator, Facharzt für Dermatologie Phlebologie Allergologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00732823
- Sponsor's protocol ID
- CW-0500-05-U337
- Status last verified
- Aug 2008
- First submitted
- 23 Jul 2008
- Last updated
- 31 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00732823
- Acronym / sponsor ID
- CW-0500-05-U337
- Conditions
- Venous Insufficiency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- ConvaTec Inc.Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- Jul 2005
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 12 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety of the Compression Device to subjects with venous insufficiency and oedema.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Profile A | Placebo comparator | Device: Placebo - No device wornNo device worn |
| Profile B | Active comparator | Device: Prototype device(unnamed)-A battery operated inflatable pneumatic cuffsFoot 40 mmHg, ankle 40 mmHg, mid-calf 35 mmHg, upper calf 30 mmHg |
| Profile C | Active comparator | Device: Prototype device(unnamed)-A battery operated inflatable pneumatic cuffsFoot 50 mmHg, ankle 50 mmHg, mid-calf 45 mmHg, upper calf 40 mmHg |
| Profile D | Active comparator | Device: Prototype device(unnamed)-A battery operated inflatable pneumatic cuffsFoot 60 mmHg, ankle 60 mmHg, mid-calf 55 mmHg, upper calf 50 mmHg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo - No device worn | Device | Profile A |
| Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs | Device | Profile B |
| Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs | Device | Profile C |
| Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs | Device | Profile D |
Primary outcome
The nature and frequency of adverse events
Distal arterial flow
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
wolfgang Vanscheidt principal investigator
Facharzt für Dermatologie Phlebologie Allergologie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs in people with Venous Insufficiency, run by ConvaTec Inc. at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The nature and frequency of adverse events. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2008.