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Sponsored by: |
FlowMedic |
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Information provided by: | FlowMedic |
ClinicalTrials.gov Identifier: | NCT00146666 |
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 |
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Peripheral Arterial Disease Intermittent Claudication |
Device: Intermittent compression |
Phase II |
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) |
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria(main):
Exclusion Criteria:
Contact: Yehudit Kraizer, Ph.D. | +972-54-3010902 | yehuditk@flowmedic.com |
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 |
Principal Investigator: | Michael Koren, MD | Jacksonville Center for Clinical Research |
Principal Investigator: | Jeffrey M Martinez, MD | Peripheral Vascular Associates |
Study ID Numbers: | 05US01 |
Study First Received: | September 3, 2005 |
Last Updated: | October 15, 2006 |
ClinicalTrials.gov Identifier: | NCT00146666 History of Changes |
Health Authority: | United States: Institutional Review Board |
Peak walking time Absolute claudication distance Claudication onset time Initial claudication distance Intermittent compression |
Arterial Occlusive Diseases Signs and Symptoms Peripheral Vascular Diseases |
Vascular Diseases Intermittent Claudication Arteriosclerosis |
Arterial Occlusive Diseases Signs and Symptoms Peripheral Vascular Diseases Vascular Diseases |
Intermittent Claudication Cardiovascular Diseases Arteriosclerosis |