Diabetic Peripheral Neuropathy Clinical Trial
Official title:
A Phase IV Clinical Trial. Effect of Pulsing Electromagnetic Fields on Lower Extremity Diabetic Neuropathy: A Pilot, Open-Label Study
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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