Peripheral Vascular Disease Clinical Trial
Official title:
To Evaluate the Increase of Local Circulation in the Leg Using the Flowaid Device
Verified date | March 2008 |
Source | Rosenblum, Jonathan I., DPM |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
This is an open label pilot study to evaluate the efficacy and the safety of the Flowaid
device in increasing local circulation in the legs.
15 patients with a diagnosis of Peripheral Vascular Disease will be enrolled in this study.
They will recieve tratment with the Flowaid device and monitored continuously by means of
Laser Doppler Flowmetry as well as by tcPO2 and Digital Thermography. Subjective data will
also be collected.
Status | Completed |
Enrollment | 0 |
Est. completion date | November 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - Give appropriate written informed consent prior to participation in the study - Have a current diagnosis of Type I or Type II Diabetes Mellitus - Have an Ankle-Arm Index between 0.35 and 0.8 on the study limb - Be in reasonable metabolic control, exhibited by HbA1C values of less than12% as observed by serum test results obtained within 3 months prior to the Screening Visit - Subject and caregiver must be accessible for, and willing to comply with, the safety procedures and available for the 12 week Follow-Up Period Exclusion Criteria: - Clinical evidence of gangrene on any part of affected foot - Active Charcot's foot on the study limb - Scheduled to undergo vascular surgery, angioplasty, or thrombolysis within 30 days from the end of the study - Malnourished as evidenced by a pre-albumin of < 11 mg/dL - Pregnancy or lactating - History of bleeding disorder - Participation in another device study for the treatment of Peripheral Vascular Disease 30 days prior to Screening Visit - Vascular procedures performed 30 days prior to Screening Visit |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
United States | New York College of Podiatric Medicine | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Rosenblum, Jonathan I., DPM |
United States,
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