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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.
 
ClinicalTrials.gov Identifier: NCT00614341
Recruitment Status : Completed
First Posted : February 13, 2008
Last Update Posted : February 13, 2008
Sponsor:
Information provided by:
MedRelief

Tracking Information
First Submitted Date  ICMJE January 30, 2008
First Posted Date  ICMJE February 13, 2008
Last Update Posted Date February 13, 2008
Study Start Date  ICMJE May 2006
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2008)
Pain reduction in diabetic patients with chronic diabetic neuropathy [ Time Frame: Day 21 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2008)
Improvement in sensation and overall foot condition [ Time Frame: Day 21 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Pulsing Electrical Fields on Lower Extremity Diabetic Neuropathy: A Pilot, Open-Label Study
Official Title  ICMJE A Phase IV Clinical Trial. Effect of Pulsing Electromagnetic Fields on Lower Extremity Diabetic Neuropathy: A Pilot, Open-Label Study
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Peripheral Neuropathy
Intervention  ICMJE Device: MedRelief SE 55
4150 Hz signal continuous or pulse, high intensity, high modulation for 6 hours each night during treatment phase
Study Arms  ICMJE Active Comparator: 1, 2
  1. Pulse MedRelief SE 55
  2. Continuous MedRelief SE 55
Intervention: Device: MedRelief SE 55
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 12, 2008)
23
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2008
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00614341
Other Study ID Numbers  ICMJE 600-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Margaret F. Fay, PhD, RN, CCRC, Director Medical-Regulatory Affairs, MedRelief, Inc.
Study Sponsor  ICMJE MedRelief
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Amy M Sprague, MD Nephrology and Rheumatology Associates
PRS Account MedRelief
Verification Date January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP