The Effects of the Magnetic Molecular Energizer (MME) on Diabetic Peripheral Neuropathy
Recruitment status was Active, not recruiting
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 (DPN).
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Randomized, Sham-Controlled Clinical Study to Evaluate The Effect of the Magnetic Molecular Energizer (MME) on Diabetic Peripheral Neuropathy|
- Improvement in neurologic function following procedure
- Improvement in DPN related pain following procedure
- Subject tolerance to the MME procedure
- 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
|Study Start Date:||July 2005|
|Estimated Study Completion Date:||January 2008|
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 receive 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.
|United States, Arizona|
|Tucson, Arizona, United States, 85711|
|United States, Michigan|
|Sterling Heights, Michigan, United States, 48313|
|United States, North Carolina|
|Mocksville, North Carolina, United States, 27208|
|United States, Ohio|
|Amri NW Oh|
|Toledo, Ohio, United States, 48313|
|United States, Washington|
|Renton, Washington, United States, 98055|
|Study Director:||Wayne R Bonlie, MD||AMRI International|