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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2009 by FlowMedic.
Recruitment status was:  Recruiting
Information provided by:
FlowMedic Identifier:
First received: September 3, 2005
Last updated: December 16, 2009
Last verified: August 2009
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 Intervention Phase
Peripheral Arterial Disease
Intermittent Claudication
Device: Intermittent compression
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of FM220 in Patients With Peripheral Arterial Disease (PAD)

Resource links provided by NLM:

Further study details as provided by FlowMedic:

Primary Outcome Measures:
  • Increase in Peak Walking Time as determined on graded treadmill test at 12 weeks

Estimated Enrollment: 90
Study Start Date: September 2005
Estimated Study Completion Date: September 2006

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00146666

Contact: Yehudit Kraizer, Ph.D. +972-54-3010902

United States, Florida
Jacksonville Center for Clinical Research Recruiting
Jacksonville, Florida, United States, 32216
Contact: Leslie Byatt    904-730-0101   
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   
Principal Investigator: Jeffrey M Martinez, MD         
Sponsors and Collaborators
Principal Investigator: Michael Koren, MD Jacksonville Clinical Research Center
Principal Investigator: Jeffrey M Martinez, MD Peripheral Vascular Associates
  More Information

Additional Information: Identifier: NCT00146666     History of Changes
Other Study ID Numbers: 05US01
Study First Received: September 3, 2005
Last Updated: December 16, 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
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms processed this record on April 24, 2017