Effect of Pulsing Electrical Fields on Lower Extremity Diabetic Neuropathy: A Pilot, Open-Label Study

NCT ID: NCT00614341

Last Updated: 2008-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2008-01-31

Brief Summary

To determine if pulsed electric field therapy reduces lower leg and foot pain associated with diabetic neuropathy and lessens the need for medication.

The MedRelief device sends a sub-threshold electric signal through the skin using electrodes as means of signal delivery. The signal or waveform, frequency and strength were created to match the characteristics of signals the body generates to help natural healing.

Detailed Description

A multi-center, randomized, open-label study involving 23 patients with chronic diabetic peripheral neuropathy meeting study entry criteria. Subjects will be randomly assigned to receive one of two treatments using an FDA cleared MedRelief device: (1) a MedRelief SE 55 device set on "pulsed" mode at 10 microsecond burst intervals 4150 Ha, or (2) a MedRelief SE 55 device set on "continuous" mode at 4150 Hz. Subjects will wear the device on target foot each night for a minimum of 6 hours over a two week (15 day treatment)period.

Subjects will complete a daily pain diary, medication form, and device use form. Subject global assessments and physician global assessments will occur at baseline, study visits Day 7, Day 15 and Day 21 (end of study).

Response to therapy will include pain reduction, improvement in sensation, improved response to vibratory stimulation and reduction of edema in study subjects.

Conditions

Diabetic Peripheral Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1, 2

1. Pulse MedRelief SE 55

2. Continuous MedRelief SE 55

Group Type: ACTIVE_COMPARATOR

MedRelief SE 55

Intervention Type: DEVICE

4150 Hz signal continuous or pulse, high intensity, high modulation for 6 hours each night during treatment phase

Interventions

MedRelief SE 55

4150 Hz signal continuous or pulse, high intensity, high modulation for 6 hours each night during treatment phase

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• currently diagnosed with diabetes mellitus
• confirmed diagnosis of diabetic peripheral neuropathy
• age 18 years to 75 years
• both males and females are eligible for study participation
• HgA1c level under 9
• Physician confirmed stable glycemic control for 3 months prior to enrollment
• baseline pain level over previous month of 5
• willing to sign IRB approved consent and follow study visit requirements
• if female of childbearing age willing to undergo urine pregnancy test

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MedRelief

INDUSTRY

Sponsor Role: lead

Responsible Party

MedRelief, Inc.

Principal Investigators

Amy M Sprague, MD

Role: PRINCIPAL_INVESTIGATOR

Nephrology and Rheumatology Associates

Locations

Nephrology and Rheumatology Associates

Augusta, Georgia, United States

Countries

United States

Other Identifiers

600-001

Identifier Type: -

Identifier Source: org_study_id