Peripheral Arterial Vascular DiseaseNCT00854516
Open Label Clinical Study to Assess the Clinical Safety of a New Compression Device in Subjects With Peripheral Arterial Vascular Disease
A study testing A new treatment approach is to have an effective working pressure combined with a low resting pressure. in people with Peripheral Arterial Vascular Disease, run by Solventum US LLC at 1 site in Germany.
Trial summary
To assess the safety of a new compression device applied to patients with an ankle brachial pressure index (ABPI) 0,5 - 0,8 who are treated for two weeks in daily routine practice. Several perfusion assessments will investigate safety under reduced compression therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Vascular Disease
- What is being tested?
- A new treatment approach is to have an effective working pressure combined with a low resting pressure.
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2009to Jan 2010
- Phase
- Interventional
- 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
- Males or females, age 18 years or older.
- Subjects suffering from peripheral arterial occlusive disease (PAOD) with an ABPI (ankle brachial pressure index) of the treated leg between 0.5 - 0.8 as measured within up to 4 weeks prior to enrollment. About 5 subjects of the study population should have an ABPI of 0.5.
- Subjects who are co-operative, willing to give written informed consent prior to study entry and willing to comply with the study protocol.
- Subjects who can walk (with or without a walking aid).
- -
Who cannot join
- Subjects with an ABPI < 0.5 or > 0.8 as measured within up to 4 weeks prior to enrollment.
- Subjects whose general condition, in the opinion of the investigator, preclude for compression therapy.
- Subjects with paralysis of the study leg
- Subjects who started or significantly changed treatment with mood altering substances (e.g. antidepressant drugs) within two weeks prior to enrollment.
- Subjects with significant instable coagulopathy; subjects treated with anticoagulant therapeutics can be included.
- Subjects who are participating in any prospective clinical study that can potentially interfere with this study.
- Subjects who are, in the opinion of the clinical investigator, unsuitable for enrollment in this study, for reasons not specified in the exclusion criteria.
- Subjects with known allergies to other materials in the compression device.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label Clinical Study to Assess the Clinical Safety of a New Compression Procedure in Subjects With Peripheral Arterial Vascular Disease
To assess the safety of a new compression device applied to patients with an ankle brachial pressure index (ABPI) 0,5 - 0,8 who are treated for two weeks in daily routine practice. Several perfusion assessments will investigate safety under reduced compression therapy.
Read the detailed description
Venous leg ulcers represent a very common clinical problem with increasing prevalence in an aging population. It is believed that venous insufficiency is the underlying condition responsible for 54-81% of leg ulcers. About 8% of leg ulcers are related to arterial insufficiency and about 14% have a mixed aetiology. Compression therapy is considered the most effective treatment for these ulcers. The overall cost of chronic venous leg ulcer is high because long term ongoing care is required. Also the quality of life of these patients is jeopardized due to long lasting ulcer treatments and inconvenient compression therapies.
Several compression products are available on the market and there is a large body of literature describing the clinical benefit of different compression systems.
A new treatment approach with the new device is to have an effective working pressure combined with a low resting pressure. A high working pressure achieved by a rigid sleeve around a patient's leg is essential to support the muscle pump, necessary for sufficient blood reflux. However the resting pressure could be low without relevant reduction of compression efficacy but with an increase in safety for patients with a mild to moderate peripheral arterial occlusive disease (PAOD). A high resting pressure is believed to be a main reason for reduced arterial skin perfusion which can result in pressure related skin damage. Accordingly most compression systems are not indicated for patients with an ABPI lower than 0.8. About 25% of patients with chronic venous insufficiency suffer from PAOD and hence are very difficult to treat with compression. With the new device, these patients could be sufficiently treated, because a low resting pressure is believed to have low influence on skin perfusion.
- Conditions
- Peripheral Arterial Vascular Disease
- Being tested
- A new treatment approach is to have an effective working pressure combined with a low resting pressure.
- Keywords
- compression therapy, 3M
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A new treatment approach is to have an effective working pressure combined with a low resting pressure.Procedure or surgery
Procedure Schedule: The total duration for study participation will be 14 days (8 visits).
Subject eligibility will be determined at the initiation visit. All eligible subjects will receive the compression device on the study leg and will return to the clinical center at day 1, 2, 3, 4, 7, 10 and 14 to assess safety. At each clinical visit (except visit day 14) the compression device will be reapplied. The study participation ends after 14 days.
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to assess the safety of the new compression device in subjects with an ankle brachial pressure index (ABPI) between 0.5-0.8.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2009 (estimated)
- Study startFeb 2009
- Primary completionOct 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial Vascular DiseaseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solventum US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 3M
- Responsible party
- Sponsor
- Investigators
- Michael Juenger, Prof. Dr. MD, Principal investigator, Universitaetsklinikum Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00854516
- Sponsor's protocol ID
- EU Study No-05-000007
- Status last verified
- Sep 2024
- First submitted
- 27 Feb 2009
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Clinical Study to Assess the Clinical Safety of a New Compression Procedure in Subjects With Peripheral Arterial Vascular Disease
- ClinicalTrials.gov ID
- NCT00854516
- Acronym / sponsor ID
- EU Study No-05-000007
- Conditions
- Peripheral Arterial Vascular Disease
- Keywords
- compression therapy, 3M
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Solventum US LLCIndustry (pharma, biotech, devices)
- Collaborators
- 3M
- Study start
- Feb 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 3 Mar 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.
To assess the safety of a new compression device applied to patients with an ankle brachial pressure index (ABPI) 0,5 - 0,8 who are treated for two weeks in daily routine practice. Several perfusion assessments will investigate safety under reduced compression therapy.
Detailed description
Venous leg ulcers represent a very common clinical problem with increasing prevalence in an aging population. It is believed that venous insufficiency is the underlying condition responsible for 54-81% of leg ulcers. About 8% of leg ulcers are related to arterial insufficiency and about 14% have a mixed aetiology. Compression therapy is considered the most effective treatment for these ulcers. The overall cost of chronic venous leg ulcer is high because long term ongoing care is required. Also the quality of life of these patients is jeopardized due to long lasting ulcer treatments and inconvenient compression therapies.
Several compression products are available on the market and there is a large body of literature describing the clinical benefit of different compression systems.
A new treatment approach with the new device is to have an effective working pressure combined with a low resting pressure. A high working pressure achieved by a rigid sleeve around a patient's leg is essential to support the muscle pump, necessary for sufficient blood reflux. However the resting pressure could be low without relevant reduction of compression efficacy but with an increase in safety for patients with a mild to moderate peripheral arterial occlusive disease (PAOD). A high resting pressure is believed to be a main reason for reduced arterial skin perfusion which can result in pressure related skin damage. Accordingly most compression systems are not indicated for patients with an ABPI lower than 0.8. About 25% of patients with chronic venous insufficiency suffer from PAOD and hence are very difficult to treat with compression. With the new device, these patients could be sufficiently treated, because a low resting pressure is believed to have low influence on skin perfusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males or females, age 18 years or older.
- Subjects suffering from peripheral arterial occlusive disease (PAOD) with an ABPI (ankle brachial pressure index) of the treated leg between 0.5 - 0.8 as measured within up to 4 weeks prior to enrollment. About 5 subjects of the study population should have an ABPI of 0.5.
- Subjects who are co-operative, willing to give written informed consent prior to study entry and willing to comply with the study protocol.
- Subjects who can walk (with or without a walking aid).
- -
Key exclusion criteria (8 listed)
- Subjects with an ABPI < 0.5 or > 0.8 as measured within up to 4 weeks prior to enrollment.
- Subjects whose general condition, in the opinion of the investigator, preclude for compression therapy.
- Subjects with paralysis of the study leg
- Subjects who started or significantly changed treatment with mood altering substances (e.g. antidepressant drugs) within two weeks prior to enrollment.
- Subjects with significant instable coagulopathy; subjects treated with anticoagulant therapeutics can be included.
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 |
|---|---|---|
| A new treatment approach is to have an effective working pressure combined with a low resting pressure.Procedure Schedule: The total duration for study participation will be 14 days (8 visits). Subject eligibility will be determined at the initiation visit. All eligible subjects will receive the compression device on the study leg and will return to the clinical center at day 1, 2, 3, 4, 7, 10 and 14 to assess safety. At each clinical visit (except visit day 14) the compression device will be reapplied. The study participation ends after 14 days. | Procedure or surgery | – |
Primary outcome
The primary objective of this study is to assess the safety of the new compression device in subjects with an ankle brachial pressure index (ABPI) between 0.5-0.8.
Time frame: 2 weeks
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 2 Oct 2024.
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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.
Michael Juenger, Prof. Dr. MD principal investigator
Universitaetsklinikum Greifswald
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A new treatment approach is to have an effective working pressure combined with a low resting pressure. in people with Peripheral Arterial Vascular Disease, run by Solventum US LLC 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 2 Oct 2024. 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.
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 primary objective of this study is to assess the safety of the new compression device in subjects with an ankle brachial pressure index (ABPI) between 0.5-0.8. (time frame: 2 weeks). 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 2 Oct 2024.