NCT00146666

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

December 17, 2009

Status Verified

August 1, 2009

First QC Date

September 3, 2005

Last Update Submit

December 16, 2009

Conditions

Peripheral Arterial DiseaseIntermittent Claudication

Keywords

Peak walking timeAbsolute claudication distanceClaudication onset timeInitial claudication distanceIntermittent compression

Outcome Measures

Primary Outcomes (1)

  • Increase in Peak Walking Time as determined on graded treadmill test at 12 weeks

Interventions

Intermittent compressionDEVICE

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

RECRUITING

Peripheral Vascular Associates

San Antonio, Texas, 78205, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Peripheral Arterial DiseaseIntermittent Claudication

Interventions

Intermittent Pneumatic Compression Devices

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Michael Koren, MD

    Jacksonville Center For Clinical Research

    PRINCIPAL INVESTIGATOR

  • Jeffrey M Martinez, MD

    Peripheral Vascular Associates

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yehudit Kraizer, Ph.D.

CONTACT

+972-54-3010902yehuditk@flowmedic.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 3, 2005

First Posted

September 7, 2005

Study Start

September 1, 2005

Study Completion

September 1, 2006

Last Updated

December 17, 2009

Record last verified: 2009-08

Locations

US(2)