This study is intended to demonstrate that exposure to a high intensity, DC electromagnetic field, as supplied by the investigational device known as the Molecular Magnetic Energizer (MME), will create a clinically meaningful improvement in pain and nerve dysfunction in the feet of patients with Diabetic Peripheral Neuropathy.

Condition	Intervention	Phase
Diabetic Neuropathies Pain Neuralgia	Procedure: MME procedure	Phase III

Further Study Details: 

Primary Outcomes: Improvement in neurologic function following procedure.; Improvement in DPN related pain following procedure.; Subject tolerance to the MME procedure
Secondary Outcomes: Neurologic function at 6 month follow-up.; Pain level at 6 month follow-up.; Quality of Life assessments at baseline, post-procedure and 6 month follow-up.
Expected Total Enrollment:  100

Diabetic Peripheral Neuropathy (DPN) affects up to 1/2 of diabetics, both Type I and II. It contributes to limb amputation, and can cause painful symptoms which are difficult to treat. Application of a high intensity, DC electromagnetic field, as supplied by the investigational device the Magnetic Molecular Energizer (MME) has shown in a pilot study with participants having DPN in their feet, to have created significant improvement in painful symptoms and improved measures of neurologic function in 7 of 10 participants. This study will enroll participants and evaluate them at baseline with regard to pain levels, nerve function and quality of life. They will then be randomized to receive 120 hr exposure to either active MME procedure, or sham procedure. Following the 120 hrs the participants will then recieve the same evaluation for pain level, nerve function and quality of life. These evaluations will be repeated a final time 6 months following. The participants will be blinded to whether they receive the active or sham procedure.

The MME procedure consists of laying on a bed with the feet lying in the space between two large electromagnetic coils which, when activated, produce a DC magnetic field measuring 5000 gauss. The participants will lay on the bed with feet in the magnetic field for 8 to 12 hours a day for 10 to 16 days in succession. Breaks are allowed, and no restraints are required. The procedure may be done at night so that participants may sleep.

Pain assessment will be done by self assessment using rating with the Visual Analogue Scale.

Neurologic function will be assessed with Cutaneous Perception Threshold testing using the Neurometer, a commercially available, FDA approved device.

Quality of life assessment will be by the Neuropathy Specific Quality of Life Questionnaire.

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Subjects with diabetic peripheral neuropathy in feet with associated pain/discomfort.
• stable and controlled diabetes with Hemoglobin A1c level less than 9.0% at entry into the study. Diabetes type I or type II accepted.
• subjects must be able to read English.

Exclusion Criteria:

• pacemakers, defibrillators, aneurysm clips, cochlear implants, any metallic particles in eyes or ferromagnetic metal shrapnel, projectile or implant in body.
• pregnant women
• concurrent neuropathy not due to diabetes.
• unstable cardiac disease or uncontrolled blood pressure.
• renal failure
• active hepatitis
• history of nerve injury to lower extremities.
• history of spinal surgery or total knee arthroplasy
• current malignancy
• alcoholism
• history of stroke
• seizure disorder
• current use of long acting narcotic medication
• skin ulceration or breakdown of the lower extremities
• peripheral vascular disease sufficient to cause extremity pain at rest.

Please refer to this study by ClinicalTrials.gov identifier  NCT00134524

Dean R Bonlie, DDS      800-265-1119    info@magneticosleep.com

Arizona
      AMRI Arizona, Tucson,  Arizona,  85711,  United States; Recruiting
Michigan
      AMRI MI, Sterling Heights,  Michigan,  48313,  United States; Recruiting
North Carolina
      AMRI NC, Mocksville,  North Carolina,  27208,  United States; Recruiting
Ohio
      AMRI NW OH, Toledo,  Ohio,  48313,  United States; Recruiting
Washington
      AMRI WA, Renton,  Washington,  98055,  United States; Recruiting

Study chairs or principal investigators

Wayne R Bonlie, MD,  Study Director,  AMRI International   

Study ID Numbers:  AMRI-DPN-01
Last Updated:  August 24, 2005
Record first received:  August 22, 2005
ClinicalTrials.gov Identifier:  NCT00134524
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-08-30