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

February 12, 2008 updated by: MedRelief

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

23

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Nephrology and Rheumatology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain reduction in diabetic patients with chronic diabetic neuropathy
Time Frame: Day 21
Day 21

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement in sensation and overall foot condition
Time Frame: Day 21
Day 21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MedRelief

Investigators

  • Principal Investigator: Amy M Sprague, MD, Nephrology and Rheumatology Associates

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

January 30, 2008

First Submitted That Met QC Criteria

February 12, 2008

First Posted (Estimate)

February 13, 2008

Study Record Updates

Last Update Posted (Estimate)

February 13, 2008

Last Update Submitted That Met QC Criteria

February 12, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 600-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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