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

Status unconfirmed · Phase 2

Conditions studied: Peripheral Arterial Disease, Intermittent Claudication

In brief

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.

Key facts

Study ID

NCT00146666

Run by

FlowMedic

People needed

90

Starts

2005-09-01

Expected to finish

2006-09-01

Last updated by the study team

2009-12-17

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.

Where it is running

• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States (enrolling)
• Peripheral Vascular Associates — San Antonio, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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