Healthy VolunteersPhase 1NCT00821808
A Pressure Relted Study Comparing a Compression Device and Profore® on Healthy Volunteers
A Phase 1 study testing Compression Device and Profore® in people with Healthy Volunteers, run by ConvaTec Inc. at 1 site in Germany.
Trial summary
This phase I Healthy Volunteer study will evaluate the pressure interface between the devices (a compression device and Profore®) and the skin, using the PicoPress(TM) pressure transducer at specified time intervals in three distinct locations on the leg, in both the sitting and standing position. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Compression Device and Profore®
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- May 2008to Jun 2008
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- over 18 years, willing and able to provide written informed consent.
- able to wear the compression device and Profore® and follow the requirements of the clinical investigation plan
- an ankle to brachial pressure index (ABPI) of 0.9 or greater
- CEAP classification C0-C2
- healthy volunteers
Who cannot join
- history of skin sensitivity to any of the components of the study product
- participated in a previous clinical study within the past 3 months
- active Deep Vein Thrombosis (DVT) or a recent DVT within the last 3 months
- exhibited any other medical condition which, according to the Investigator, justifies the subject's exclusion from the study
- leg sizes outside the following range:
- Ankle - 12cm to 44cm
- Calf - 22cm to 60cm
- Below knee - 22cm to 68cm
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Open-label, One-arm, Active Controlled Study to Evaluate the Pressure Interface Between Device and Skin of a Compression Device and Profore® on Healthy Volunteers
This phase I Healthy Volunteer study will evaluate the pressure interface between the devices (a compression device and Profore®) and the skin, using the PicoPress(TM) pressure transducer at specified time intervals in three distinct locations on the leg, in both the sitting and standing position. It will also assess the variability of interface pressure following application under each test device for each subject over a period of three days (three separate applications).
- Conditions
- Healthy Volunteers
- Being tested
- Compression Device, Profore®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression DeviceDevice
The compression device will be worn for 8 hours each day on one leg. The device will be applied by the same clinician every morning.Interface pressure measurements will be made in both the sitting and standing position at three locations on the leg at the following time intervals:
- Immediately following device application
- 1 hour
- 4 hours
- 8 hours
Profore®Device
Profore® will be worn for 8 hours each day on opposite leg. Profore® will be applied by the same clinician every morning.Interface pressure measurements will be made in both the sitting and standing position at three locations on the leg at the following time intervals:
- Immediately following device application
- 1 hour
- 4 hours
- 8 hours
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the amount of pressure and the variability of interface pressure of the two devices on application
Measured: 3 days
To evaluate pressure change of the interface pressure with the compression device and Profore® over time
Measured: 3 days
Safety will be evaluated by the nature and frequency of adverse events.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2009 (estimated)
- Study startMay 2008
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- ConvaTec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wolfgang Vanscheidt, MD, Principal investigator, Hautarzt Phlebologe Allergologe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00821808
- Sponsor's protocol ID
- CW-0500-08-U347
- Status last verified
- Oct 2015
- First submitted
- 13 Jan 2009
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Open-label, One-arm, Active Controlled Study to Evaluate the Pressure Interface Between Device and Skin of a Compression Device and Profore® on Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00821808
- Acronym / sponsor ID
- CW-0500-08-U347
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- ConvaTec Inc.Industry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 14 Jan 2009 (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.
This phase I Healthy Volunteer study will evaluate the pressure interface between the devices (a compression device and Profore®) and the skin, using the PicoPress(TM) pressure transducer at specified time intervals in three distinct locations on the leg, in both the sitting and standing position. It will also assess the variability of interface pressure following application under each test device for each subject over a period of three days (three separate applications).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- over 18 years, willing and able to provide written informed consent.
- able to wear the compression device and Profore® and follow the requirements of the clinical investigation plan
- an ankle to brachial pressure index (ABPI) of 0.9 or greater
- CEAP classification C0-C2
- healthy volunteers
Key exclusion criteria (8 listed)
- history of skin sensitivity to any of the components of the study product
- participated in a previous clinical study within the past 3 months
- active Deep Vein Thrombosis (DVT) or a recent DVT within the last 3 months
- exhibited any other medical condition which, according to the Investigator, justifies the subject's exclusion from the study
- leg sizes outside the following range:
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 |
|---|---|---|
| Compression DeviceThe compression device will be worn for 8 hours each day on one leg. The device will be applied by the same clinician every morning.Interface pressure measurements will be made in both the sitting and standing position at three locations on the leg at the following time intervals: * Immediately following device application * 1 hour * 4 hours * 8 hours | Device | – |
| Profore®Profore® will be worn for 8 hours each day on opposite leg. Profore® will be applied by the same clinician every morning.Interface pressure measurements will be made in both the sitting and standing position at three locations on the leg at the following time intervals: * Immediately following device application * 1 hour * 4 hours * 8 hours | Device | – |
Primary outcome
To evaluate the amount of pressure and the variability of interface pressure of the two devices on application
Time frame: 3 days
To evaluate pressure change of the interface pressure with the compression device and Profore® over time
Time frame: 3 days
Safety will be evaluated by the nature and frequency of adverse events.
Time frame: 3 days
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 14 Oct 2015.
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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, MD principal investigator
Hautarzt Phlebologe Allergologe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Compression Device and Profore® in people with Healthy Volunteers, 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 8 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 14 Oct 2015. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
To evaluate the amount of pressure and the variability of interface pressure of the two devices on application (time frame: 3 days). The study lists 3 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 14 Oct 2015.