ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Sponsor:
Information provided by:
FlowMedic

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 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

Resource links provided by the National Library of Medicine

U.S. FDA Resources




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


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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.

Information from the National Library of Medicine

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


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

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