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

Completed · Phase 4

Conditions studied: Diabetic Peripheral Neuropathy

In brief

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.

Key facts

Study ID

NCT00614341

Run by

MedRelief

People needed

23

Starts

2006-05-01

Expected to finish

2008-01-01

Last updated by the study team

2008-02-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Nephrology and Rheumatology Associates — Augusta, Georgia, United States

Full record on ClinicalTrials.gov

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