Evaluation of FM220 in Patients With Peripheral Arterial Disease (PAD)
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ClinicalTrials.gov Identifier: NCT00146666 |
Recruitment Status
: Unknown
Verified August 2009 by FlowMedic.
Recruitment status was: Recruiting
First Posted
: September 7, 2005
Last Update Posted
: December 17, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Peripheral Arterial Disease Intermittent Claudication | Device: Intermittent compression | Phase 2 |
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 |

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

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Ages Eligible for Study: | 40 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria(main):
- 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.
Exclusion Criteria:
- 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.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00146666
Contact: Yehudit Kraizer, Ph.D. | +972-54-3010902 | yehuditk@flowmedic.com |
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 |
Principal Investigator: | Michael Koren, MD | Jacksonville Clinical Research Center | |
Principal Investigator: | Jeffrey M Martinez, MD | Peripheral Vascular Associates |
ClinicalTrials.gov Identifier: | NCT00146666 History of Changes |
Other Study ID Numbers: |
05US01 |
First Posted: | September 7, 2005 Key Record Dates |
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 |