Effect of Pulsing Electrical Fields on Lower Extremity Diabetic Neuropathy: A Pilot, Open-Label Study (DPN)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase IV Clinical Trial. Effect of Pulsing Electromagnetic Fields on Lower Extremity Diabetic Neuropathy: A Pilot, Open-Label Study|
- Pain reduction in diabetic patients with chronic diabetic neuropathy [ Time Frame: Day 21 ] [ Designated as safety issue: Yes ]
- Improvement in sensation and overall foot condition [ Time Frame: Day 21 ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2006|
|Study Completion Date:||January 2008|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
Active Comparator: 1, 2
Device: MedRelief SE 55
4150 Hz signal continuous or pulse, high intensity, high modulation for 6 hours each night during treatment phase
Other Name: MedRelief SE 55
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.
|United States, Georgia|
|Nephrology and Rheumatology Associates|
|Augusta, Georgia, United States, 30909|
|Principal Investigator:||Amy M Sprague, MD||Nephrology and Rheumatology Associates|