Evaluation of FM220 in Patients With Peripheral Arterial Disease (PAD)

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
Peripheral Arterial Disease; Intermittent Claudication	Device: Intermittent compression	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	90 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Evaluation of FM220 in Patients With Peripheral Arterial Disease (PAD)
Study Start Date :	September 2005
Estimated Study Completion Date :	September 2006

Arms and Interventions

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Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Increase in Peak Walking Time as determined on graded treadmill test at 12 weeks

Eligibility Criteria

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Ages Eligible for Study:	40 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Yehudit Kraizer, Ph.D.	+972-54-3010902	yehuditk@flowmedic.com

Locations

United States, Florida
Jacksonville Center for Clinical Research	Recruiting
Jacksonville, Florida, United States, 32216
Contact: Leslie Byatt 904-730-0101 LByatt@encoredocs.com
Principal Investigator: Michael Koren, MD
United States, Texas
Peripheral Vascular Associates	Recruiting
San Antonio, Texas, United States, 78205
Contact: Kathy Britt, RN 210-225-6508 kbritt@pvasatx.com
Principal Investigator: Jeffrey M Martinez, MD

Sponsors and Collaborators

FlowMedic

Investigators

Principal Investigator:	Michael Koren, MD	Jacksonville Clinical Research Center
Principal Investigator:	Jeffrey M Martinez, MD	Peripheral Vascular Associates

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00146666 History of Changes
Other Study ID Numbers:	05US01
First Posted:	September 7, 2005
Last Update Posted:	December 17, 2009
Last Verified:	August 2009

Keywords provided by FlowMedic:

Peak walking time; Absolute claudication distance; Claudication onset time; Initial claudication distance; Intermittent compression

Additional relevant MeSH terms:

Peripheral Arterial Disease; Peripheral Vascular Diseases; Intermittent Claudication; Atherosclerosis; Arteriosclerosis	Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms