Evaluation of FM220 in Patients With Peripheral Arterial Disease (PAD)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by FlowMedic.
Recruitment status was Recruiting
Information provided by:
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.
Peripheral Arterial Disease
Device: Intermittent compression
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||Evaluation of FM220 in Patients With Peripheral Arterial Disease (PAD)
Primary Outcome Measures:
- Increase in Peak Walking Time as determined on graded treadmill test at 12 weeks
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
|Ages Eligible for Study:
||40 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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 ClinicalTrials.gov identifier: NCT00146666
|Jacksonville Center for Clinical Research
|Jacksonville, Florida, United States, 32216 |
|Contact: Leslie Byatt 904-730-0101 LByatt@encoredocs.com |
|Principal Investigator: Michael Koren, MD |
|Peripheral Vascular Associates
|San Antonio, Texas, United States, 78205 |
|Contact: Kathy Britt, RN 210-225-6508 firstname.lastname@example.org |
|Principal Investigator: Jeffrey M Martinez, MD |
||Michael Koren, MD
||Jacksonville Center for Clinical Research
||Jeffrey M Martinez, MD
||Peripheral Vascular Associates
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 3, 2005
||December 16, 2009
||United States: Institutional Review Board
Keywords provided by FlowMedic:
Peak walking time
Absolute claudication distance
Claudication onset time
Initial claudication distance
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on February 27, 2015
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Signs and Symptoms