Evaluation of FM220 in Patients With Peripheral Arterial Disease (PAD)
NCT ID: NCT00146666
Last Updated: 2009-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
90 participants
INTERVENTIONAL
2005-09-30
2006-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Intermittent compression
Eligibility Criteria
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Inclusion Criteria
2. Peripheral arterial disease as determined by resting ABI\<0.90.
3. Reduction in post exercise Ankle Brachial Index (ABI) of \> 20% in the symptomatic limb.
4. Stable claudication for the past three months
5. Baseline PWT between 1 and 10 minutes
6. 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.
7. 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.
Exclusion Criteria
2. Non compressible arteries as defined by ABI\>1.1
3. Clinical evidence of acute or subacute superficial or deep venous thrombosis confirmed by continuous-wave Doppler in the affected extremity.
4. Deep venous insufficiency on clinical grounds or by lab measurements.
5. Prior below-knee surgical revascularization procedure within the last 6 months.
6. Significant likelihood of lower extremity arterial revascularization procedure within the next 6 months.
7. Ulcer, cellulitis, skin conditions, or superficial thrombophlebitis in regions covered by the compression device preventing use of the device.
8. Acute pulmonary embolism.
9. Osteomyelitis of the lower extremity.
10. Gangrene of the lower extremity.
11. Acute limb ischemia.
12. Clinical scenarios in which increased venous or lymphatic return is undesirable.
13. Painful calf conditions which would exclude use of the pump.
14. 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.
15. Pulmonary edema.
16. 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.
17. Critical leg ischemia with evidence of rest pain, ischemic ulceration, gangrene.
18. Participation in any clinical trial within the past 30 days.
19. Morbid obesity, defined by BMI\>40, weight greater than 300 lbs or leg circumference greater than 19.7 inches.
20. Pregnancy.
40 Years
ALL
No
Sponsors
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FlowMedic
INDUSTRY
Principal Investigators
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Michael Koren, MD
Role: PRINCIPAL_INVESTIGATOR
Jacksonville Center For Clinical Research
Jeffrey M Martinez, MD
Role: PRINCIPAL_INVESTIGATOR
Peripheral Vascular Associates
Locations
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Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Peripheral Vascular Associates
San Antonio, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Leslie Byatt
Role: primary
Kathy Britt, RN
Role: primary
Related Links
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Related Info
Other Identifiers
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05US01
Identifier Type: -
Identifier Source: org_study_id