Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Rosenblum, Jonathan I., DPM
This is a 15 patient pilot study to evaluate efficacy and safety of use of the Flowaid device in increasing local circulation in the legs of patients with Peripheral Vascular Disease. Patients will be evaluated and scored prior to treatment and then treated with the Flowaid device for a period of two hours. During the treatment period patients will be continuously monitored by digital thermograph as well as by tcPO2 and Laser Doppler Flowmetry. Patients will also be monitored for a brief period immediately after cessation of treatment to evaluate continued effect of the device on local circulation in the leg.
The study will be individually controlled with each patients treated leg evaluated against the contralateral non- treated leg.
Subjective data including distance able to walk, pain and vibratory sensation threshold will also be collected and evaluated appropriately.
Age
18–90
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Evaluation of the Effect of the Flowaid Device in Increasing Local Circulation in the Leg
