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

NCT00538226 | Completed Phase 1 DMC

• 1 other identifier: tali725
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peripheral Vascular Disease

Interventions

External Electric Muscle Stimulation DEVICE

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 qualify 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

Sponsors & Collaborators

• Rosenblum, Jonathan I., DPM: lead

Study Sites (1)

New York College of Podiatric Medicine

New York, New York, 10035, United States

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Eileen Chusid, PHD

  New York College of Podiatric Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV

Study Record Dates

• First Submitted: September 29, 2007
• First Posted: October 2, 2007
• Study Start: October 1, 2007
• Study Completion: November 1, 2007
• Last Updated: March 4, 2008

Record last verified: 2008-03

Locations

US (1)