Peripheral Arterial DiseasePhase 2NCT00146666
Evaluation of FM220 in Patients With Peripheral Arterial Disease (PAD)
A Phase 2 study testing Intermittent compression in people with Peripheral Arterial Disease and Intermittent Claudication, run by FlowMedic at 2 sites in United States.
Trial summary
The purpose of this study is to determine whether 12 weeks of daily home use of the FM220 in the most affected leg of patients with PAD and claudication, will improve peak walking time (PWT) at three months as compared with a non-treated control group. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Intermittent Claudication
- What is being tested?
- Intermittent compression
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2005to Sep 2006
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 40 or more.
- Peripheral arterial disease as determined by resting ABI<0.90.
- Reduction in post exercise Ankle Brachial Index (ABI) of > 20% in the symptomatic limb.
- Stable claudication for the past three months
- Baseline PWT between 1 and 10 minutes
- If the patient is under claudication drug therapy (eg. cilostazol and pentoxifvlline) the use and dose of these drugs has been stable for the last 60 days.
- If the patient is receiving of statin and antiplatelet therapy, the use and dose of these drugs has been stable for the last 60 days.
Who cannot join
- Any active pathological heart, muscular, neurological, orthopedic, cognitive or pulmonary disease which might interfere with patient compliance or ability to walk on a treadmill in the opinion of the investigator.
- Non compressible arteries as defined by ABI>1.1
- Clinical evidence of acute or subacute superficial or deep venous thrombosis confirmed by continuous-wave Doppler in the affected extremity.
- Deep venous insufficiency on clinical grounds or by lab measurements.
- Prior below-knee surgical revascularization procedure within the last 6 months.
- Significant likelihood of lower extremity arterial revascularization procedure within the next 6 months.
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- Ulcer, cellulitis, skin conditions, or superficial thrombophlebitis in regions covered by the compression device preventing use of the device.
- Acute pulmonary embolism.
- Osteomyelitis of the lower extremity.
- Gangrene of the lower extremity.
- Acute limb ischemia.
- Clinical scenarios in which increased venous or lymphatic return is undesirable.
- Painful calf conditions which would exclude use of the pump.
- Peripheral neuropathy that, in the opinion of the investigator, would prevent patient from accurately assessing claudication symptoms or identifying Cutaneous comfort of the device Vein ligation.
- Pulmonary edema.
- Significant aorto-iliac disease as demonstrated by physical examination or objective testing. Absence of aorto-iliac disease must be documented by segmental testing performed within 90 days of study enrollment.
- Critical leg ischemia with evidence of rest pain, ischemic ulceration, gangrene.
- Participation in any clinical trial within the past 30 days.
- Morbid obesity, defined by BMI>40, weight greater than 300 lbs or leg circumference greater than 19.7 inches.
- Pregnancy.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Leslie Byatt, 904-730-0101, LByatt@encoredocs.com
Michael Koren, MD
- Recruiting
Peripheral Vascular Associates
San Antonio, Texas, 78205
Kathy Britt, RN, 210-225-6508, kbritt@pvasatx.com
Jeffrey M Martinez, MD
About this study
The purpose of this study is to determine whether 12 weeks of daily home use of the FM220 in the most affected leg of patients with PAD and claudication, will improve peak walking time (PWT) at three months as compared with a non-treated control group.
- Being tested
- Intermittent compression
- Keywords
- Peak walking time, Absolute claudication distance, Claudication onset time, Initial claudication distance, Intermittent compression
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent compressionDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in Peak Walking Time as determined on graded treadmill test at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startSep 2005
- Study completionSep 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FlowMedic
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael Koren, MD, Principal investigator, Jacksonville Center For Clinical ResearchJeffrey M Martinez, MD, Principal investigator, Peripheral Vascular Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00146666
- Sponsor's protocol ID
- 05US01
- Status last verified
- Aug 2009
- First submitted
- 3 Sep 2005
- Last updated
- 17 Dec 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of FM220 in Patients With Peripheral Arterial Disease (PAD)
- ClinicalTrials.gov ID
- NCT00146666
- Acronym / sponsor ID
- 05US01
- Keywords
- Peak walking time, Absolute claudication distance, Claudication onset time, Initial claudication distance, Intermittent compression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- FlowMedicIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Study completion
- Sep 2006 (estimated)
- First posted
- 7 Sep 2005 (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.
The purpose of this study is to determine whether 12 weeks of daily home use of the FM220 in the most affected leg of patients with PAD and claudication, will improve peak walking time (PWT) at three months as compared with a non-treated control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients aged 40 or more.
- Peripheral arterial disease as determined by resting ABI<0.90.
- Reduction in post exercise Ankle Brachial Index (ABI) of > 20% in the symptomatic limb.
- Stable claudication for the past three months
- Baseline PWT between 1 and 10 minutes
Key exclusion criteria (20 listed)
- Any active pathological heart, muscular, neurological, orthopedic, cognitive or pulmonary disease which might interfere with patient compliance or ability to walk on a treadmill in the opinion of the investigator.
- Non compressible arteries as defined by ABI>1.1
- Clinical evidence of acute or subacute superficial or deep venous thrombosis confirmed by continuous-wave Doppler in the affected extremity.
- Deep venous insufficiency on clinical grounds or by lab measurements.
- Prior below-knee surgical revascularization procedure within the last 6 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 |
|---|---|---|
| Intermittent compression | Device | – |
Primary outcome
Increase in Peak Walking Time as determined on graded treadmill test at 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2009.
- Related InfoLink provided by the sponsor.
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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 Koren, MD principal investigator
Jacksonville Center For Clinical Research
Jeffrey M Martinez, MD principal investigator
Peripheral Vascular Associates
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intermittent compression in people with Peripheral Arterial Disease and Intermittent Claudication, run by FlowMedic at 2 sites in United States.
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 7 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 17 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yehudit Kraizer, Ph.D. (+972-54-3010902, yehuditk@flowmedic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in Peak Walking Time as determined on graded treadmill test at 12 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 17 Dec 2009.