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

Phase 4

Completed

• Conditions: Diabetic Peripheral Neuropathy
• Interventions: Device: MedRelief SE 55

• Registration Number: NCT00614341
• Lead Sponsor: MedRelief

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.

Study Timeline

• Study Start: 2006-05
• Primary Completion: 2007-12
• Status Verified: 2008-01
• Study Completion: 2008-01
• Study First Submitted: 2008-01-30
• Study First Submitted QC: 2008-02-12
• Last Update Submitted: 2008-02-12
• Study First Posted: 2008-02-13
• Last Update Posted: 2008-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1, 2	MedRelief SE 55	1. Pulse MedRelief SE 55 2. Continuous MedRelief SE 55

Primary Outcome Measures

Name	Time	Method
Pain reduction in diabetic patients with chronic diabetic neuropathy	Day 21

Secondary Outcome Measures

Name	Time	Method
Improvement in sensation and overall foot condition	Day 21

Trial Locations

Locations (1)

Nephrology and Rheumatology Associates; 🇺🇸 Augusta, Georgia, United States