View Clinical Trial (Medical Research Study)
Evaluation of FM220 in Patients With Peripheral Arterial Disease (PAD)
| City: |
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Jacksonville |
| State: |
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Florida |
| Zip Code: |
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32216 |
| Conditions: |
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Peripheral Arterial Disease - Intermittent Claudication |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria(main):
1. Patients aged 40 or more.
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:
1. 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.
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.
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| NCT ID: |
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NCT00146666 |
| Primary Contact: |
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Principal Investigator
Michael Koren, MD
Jacksonville Center for Clinical Research
Yehudit Kraizer, Ph.D.
Phone: +972-54-3010902
Email: yehuditk@flowmedic.com
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| Backup Contact: |
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N/A |
| Location Contact: |
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Jacksonville, Florida 32216
United States
Leslie Byatt
Phone: 904-730-0101
Email: LByatt@encoredocs.com
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
| Modifications to this listing: |
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