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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase IV Clinical Trial. Effect of Pulsing Electromagnetic Fields on Lower Extremity Diabetic Neuropathy: A Pilot, Open-Label Study

Conditions
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Diabetic Peripheral Neuropathy

Intervention / Treatment
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* Device: MedRelief SE 55


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1, 2<br>Pulse MedRelief SE 55 Continuous MedRelief SE 55 | Device: MedRelief SE 55<br>* 4150 Hz signal continuous or pulse, high intensity, high modulation for 6 hours each night during treatment phase<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain reduction in diabetic patients with chronic diabetic neuropathy |  | Day 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in sensation and overall foot condition |  | Day 21 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus, neuropathy, distal symmetric polyneuropathy, pulsed electric fild