Evaluation of the Effect of the Flowaid Device in Increasing Local Circulation in the Leg

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.

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Key information

Conditions

Peripheral Vascular Disease Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

New York College of Podiatric Medicine

New York, 10035, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

External Electric Muscle Stimulation

Device

Sponsors and collaborators

Lead sponsor

Rosenblum, Jonathan I., DPM

Indiv

Registry information

Official study title

To Evaluate the Increase of Local Circulation in the Leg Using the Flowaid Device

Important dates

Study start: 2007
Study completion: 2007
First posted: Oct 2, 2007
Registry last updated: Mar 4, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed