Peripheral Arterial DiseaseNCT00762086
Safety and Efficacy Study of a New Intermittent Pneumatic Compression Device to Treat Patients With Peripheral Arterial Disease (PAD) Stage II
A study testing AngioPress Intermittent pneumatic compression (IPC) Device and Medications and Standard walking exercises in people with Peripheral Arterial Disease, run by Mego Afek Ltd. at 4 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of new intermittent pneumatic compression device on initial claudication distance in patients with Peripheral Arterial Disease stage II Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- AngioPress Intermittent pneumatic compression (IPC) Device and Medications and Standard walking exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Mar 2009to Jan 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subject 18 to 90 years, of any race.
- Patients with proven Peripheral Arterial Disease (PAD) in Doppler Ultrasound and Ankle-Brachial Pressure Index (ABPI ≤ 0.9 in one leg)
- Subject with stable (>3 month) PAD Fontaine Stage II.
- Aortoiliac vessels with no significant hemodynamic disturbances , as confirmed by recent (<30 days) clinical examination
- Subject has intermittent claudication and claudication pain of the calf
- Subject has stable intermittent claudication (>3 month and not more than one year) with initial claudication distance not more than 250 meters, as determined by treadmill test (3.2 km/h, 10% grade)
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- Subject willing to participate as evidenced by signing the written informed consent.
- Treatment with Aspirin or Clopidogrel for at least 7 days
- Willingness to undergo standardized walking exercise
Who cannot join
- Ankle-Brachial Pressure Index (ABI) above 0.8 in both legs. In Diabetic patients with no compressible arteries ABI above 40 mm/Hg of the higher pressure measured in both arms.
- Inability to walk
- Chronic respiratory insufficiency (severe obstructive or restrictive)
- Coronary artery disease with angina
- Stroke, myocardial infarction or other acute vascular events in the last 3 months
- Mild-Severe congestive heart failure
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- Degenerative or inflammatory hip, knee, ankle or foot joint lesions interfering with walking
- Spinal stenosis or disc lesions with lower limb motor sensory defects
- Leg trauma, limb or skin infection or edema
- Recent (6 months) abdominal, cardiothoracic, vascular or orthopedic (lower limb) surgery
- Subject after crural or pedal bypass surgery
- Subject with neuropathy
- Uncontrolled arterial hypertension
- Morbid obesity (BMI >35.0)
- Need for concomitant medication with potential vascular activity
- Routinely use of pain relief medications (i.e. NSAIDs, Narcotics etc)
- Expected weak compliance
- Subject requires surgical or endovascular intervention for PAD
- Subject has known allergy to device components (sleeve fabric).
- Subject has medical conditions that may be worsened by concomitant use of the device (i.e. recent (1 year) Deep Vein Thrombosis).
- Subject participates in any other clinical study at the same time
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Germany2 sites
Praxis für Angiology
Munich
Praxis für Gefäßmedizin am Tegernsee
Rottach-Egern, 83700
About this study
Official title: A Prospective, Randomized, Multi-center Clinical Trial to Evaluate the Efficacy and Safety of a New Intermittent Pneumatic Compression Device on Initial Claudication Distance in Patients With Peripheral Arterial Disease Stage II.
The purpose of this study is to evaluate the safety and efficacy of new intermittent pneumatic compression device on initial claudication distance in patients with Peripheral Arterial Disease stage II
Read the detailed description
Patients with Peripheral Arterial Disease (PAD) suffer from symptoms such as intermittent claudication, limb and foot pain and tissue lesions, which are difficult to treat. In recent years, there have been reports demonstrating reduction of these symptoms by use of compressible sleeve devices.
This clinical study aims at demonstrating the safety and effectiveness of this device in treating PAD symptoms.
- Conditions
- Peripheral Arterial Disease
- Being tested
- AngioPress Intermittent pneumatic compression (IPC) Device, Medications and Standard walking exercises
- Keywords
- Peripheral Arterial Disease, intermittent pneumatic compression treatment, Initial claudication
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AngioPress Intermittent pneumatic compression (IPC) DeviceDevice
Treatment with Intermittent pneumatic compression (IPC) for PAD
Medications and Standard walking exercisesOther
Aspirin/Clopidegrol and Standard walking exercises
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Active comparator | AngioPress Intermittent pneumatic compression (IPC) Device Receives: Device: AngioPress Intermittent pneumatic compression (IPC) Device |
| Control Group | Other | Aspirin/Clopidegrol and Standard walking exercises Receives: Other: Medications and Standard walking exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Claudication Distance (ACD)
Absolute walking distance is measured by walking on a treadmill until the point when the subject is inable to walk anymore due to pain in the leg. The walking distance is measured by meters
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study startMar 2009
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Arterial 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mego Afek Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Avigdor Zelikovski, Prof., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00762086
- Sponsor's protocol ID
- HM-AHR-01
- Status last verified
- Aug 2012
- First submitted
- 28 Sep 2008
- Last updated
- 31 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multi-center Clinical Trial to Evaluate the Efficacy and Safety of a New Intermittent Pneumatic Compression Device on Initial Claudication Distance in Patients With Peripheral Arterial Disease Stage II.
- ClinicalTrials.gov ID
- NCT00762086
- Acronym / sponsor ID
- HM-AHR-01
- Conditions
- Peripheral Arterial Disease
- Keywords
- Peripheral Arterial Disease, intermittent pneumatic compression treatment, Initial claudication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Mego Afek Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 30 Sep 2008 (estimated)
- Results
- Posted 27 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and efficacy of new intermittent pneumatic compression device on initial claudication distance in patients with Peripheral Arterial Disease stage II
Detailed description
Patients with Peripheral Arterial Disease (PAD) suffer from symptoms such as intermittent claudication, limb and foot pain and tissue lesions, which are difficult to treat. In recent years, there have been reports demonstrating reduction of these symptoms by use of compressible sleeve devices.
This clinical study aims at demonstrating the safety and effectiveness of this device in treating PAD symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Active comparator | Device: AngioPress Intermittent pneumatic compression (IPC) DeviceAngioPress Intermittent pneumatic compression (IPC) Device |
| Control Group | Other | Other: Medications and Standard walking exercisesAspirin/Clopidegrol and Standard walking exercises |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female subject 18 to 90 years, of any race.
- Patients with proven Peripheral Arterial Disease (PAD) in Doppler Ultrasound and Ankle-Brachial Pressure Index (ABPI ≤ 0.9 in one leg)
- Subject with stable (>3 month) PAD Fontaine Stage II.
- Aortoiliac vessels with no significant hemodynamic disturbances , as confirmed by recent (<30 days) clinical examination
- Subject has intermittent claudication and claudication pain of the calf
Key exclusion criteria (21 listed)
- Ankle-Brachial Pressure Index (ABI) above 0.8 in both legs. In Diabetic patients with no compressible arteries ABI above 40 mm/Hg of the higher pressure measured in both arms.
- Inability to walk
- Chronic respiratory insufficiency (severe obstructive or restrictive)
- Coronary artery disease with angina
- Stroke, myocardial infarction or other acute vascular events in the last 3 months
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 |
|---|---|---|
| AngioPress Intermittent pneumatic compression (IPC) DeviceTreatment with Intermittent pneumatic compression (IPC) for PAD | Device | Treatment Group |
| Medications and Standard walking exercisesAspirin/Clopidegrol and Standard walking exercises | Other | Control Group |
Primary outcome
Absolute Claudication Distance (ACD)
Time frame: 3 months
Absolute walking distance is measured by walking on a treadmill until the point when the subject is inable to walk anymore due to pain in the leg. The walking distance is measured by meters
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Avigdor Zelikovski, Prof. principal investigator
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AngioPress Intermittent pneumatic compression (IPC) Device and Medications and Standard walking exercises in people with Peripheral Arterial Disease, run by Mego Afek Ltd. at 4 sites in 2 countries.
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 9 inclusion and 21 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 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Israel. 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?
Yes. Results are posted in the registry (first posted 27 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Absolute Claudication Distance (ACD) (time frame: 3 months). 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 Aug 2012.