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

This study has been completed.
Sponsor:
Information provided by:
MedRelief
ClinicalTrials.gov Identifier:
NCT00614341
First received: January 30, 2008
Last updated: February 12, 2008
Last verified: January 2008
  Purpose

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 Intervention Phase
Diabetic Peripheral Neuropathy
Device: MedRelief SE 55
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by MedRelief:

Primary Outcome Measures:
  • Pain reduction in diabetic patients with chronic diabetic neuropathy [ Time Frame: Day 21 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Improvement in sensation and overall foot condition [ Time Frame: Day 21 ] [ Designated as safety issue: Yes ]

Enrollment: 23
Study Start Date: May 2006
Study Completion Date: January 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: MedRelief SE 55

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

-

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00614341

Locations
United States, Georgia
Nephrology and Rheumatology Associates
Augusta, Georgia, United States, 30909
Sponsors and Collaborators
MedRelief
Investigators
Principal Investigator: Amy M Sprague, MD Nephrology and Rheumatology Associates
  More Information

No publications provided

Responsible Party: Margaret F. Fay, PhD, RN, CCRC, Director Medical-Regulatory Affairs, MedRelief, Inc.
ClinicalTrials.gov Identifier: NCT00614341     History of Changes
Other Study ID Numbers: 600-001
Study First Received: January 30, 2008
Last Updated: February 12, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by MedRelief:
diabetes mellitus
neuropathy
distal symmetric polyneuropathy
pulsed electric fild

Additional relevant MeSH terms:
Diabetic Neuropathies
Peripheral Nervous System Diseases
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on July 28, 2014