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Evaluation of FM220 in Patients With Peripheral Arterial Disease (PAD)
This study is currently recruiting participants.
Verified by FlowMedic, October 2006
Sponsored by: FlowMedic
Information provided by: FlowMedic
ClinicalTrials.gov Identifier: NCT00146666
  Purpose

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 II

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Evaluation of FM220 in Patients With Peripheral Arterial Disease (PAD)

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
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00146666

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 Center for Clinical Research
Principal Investigator: Jeffrey M Martinez, MD Peripheral Vascular Associates
  More Information

Related Info  This link exits the ClinicalTrials.gov site

Study ID Numbers: 05US01
Study First Received: September 3, 2005
Last Updated: October 15, 2006
ClinicalTrials.gov Identifier: NCT00146666  
Health Authority: United States: Institutional Review Board

Keywords provided by FlowMedic:
Peak walking time
Absolute claudication distance
Claudication onset time
Initial claudication distance
Intermittent compression

Study placed in the following topic categories:
Arterial Occlusive Diseases
Signs and Symptoms
Peripheral Vascular Diseases
Vascular Diseases
Intermittent Claudication
Arteriosclerosis

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009