COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00614341
Recruitment Status : Completed
First Posted : February 13, 2008
Last Update Posted : February 13, 2008
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Diabetic Peripheral Neuropathy Device: MedRelief SE 55 Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1, 2
  1. Pulse MedRelief SE 55
  2. Continuous MedRelief SE 55
Device: MedRelief SE 55
4150 Hz signal continuous or pulse, high intensity, high modulation for 6 hours each night during treatment phase

Primary Outcome Measures :
  1. Pain reduction in diabetic patients with chronic diabetic neuropathy [ Time Frame: Day 21 ]

Secondary Outcome Measures :
  1. Improvement in sensation and overall foot condition [ Time Frame: Day 21 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00614341

Layout table for location information
United States, Georgia
Nephrology and Rheumatology Associates
Augusta, Georgia, United States, 30909
Sponsors and Collaborators
Layout table for investigator information
Principal Investigator: Amy M Sprague, MD Nephrology and Rheumatology Associates

Layout table for additonal information
Responsible Party: Margaret F. Fay, PhD, RN, CCRC, Director Medical-Regulatory Affairs, MedRelief, Inc. Identifier: NCT00614341    
Other Study ID Numbers: 600-001
First Posted: February 13, 2008    Key Record Dates
Last Update Posted: February 13, 2008
Last Verified: January 2008
Keywords provided by MedRelief:
diabetes mellitus
distal symmetric polyneuropathy
pulsed electric fild
Additional relevant MeSH terms:
Layout table for MeSH terms
Peripheral Nervous System Diseases
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases