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

This study has been completed.
Sponsor:
Information provided by:
Rosenblum, Jonathan I., DPM
ClinicalTrials.gov Identifier:
NCT00538226
First received: September 29, 2007
Last updated: March 3, 2008
Last verified: March 2008
  Purpose

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.


Condition Intervention Phase
Peripheral Vascular Disease
Device: External Electric Muscle Stimulation
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: To Evaluate the Increase of Local Circulation in the Leg Using the Flowaid Device

Resource links provided by NLM:


Further study details as provided by Rosenblum, Jonathan I., DPM:

Study Start Date: October 2007
Study Completion Date: November 2007
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00538226

Locations
United States, New York
New York College of Podiatric Medicine
New York, New York, United States, 10035
Sponsors and Collaborators
Rosenblum, Jonathan I., DPM
Investigators
Study Director: Eileen Chusid, PHD New York College of Podiatric Medicine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00538226     History of Changes
Other Study ID Numbers: tali725
Study First Received: September 29, 2007
Last Updated: March 3, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014