Status:
UNKNOWN
The Effects of the Magnetic Molecular Energizer (MME) on Diabetic Peripheral Neuropathy
Lead Sponsor:
Advanced Magnetic Research Institute International
Conditions:
Diabetic Neuropathies
Pain
Eligibility:
All Genders
18-79 years
Phase:
PHASE3
Brief Summary
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 creat...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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 arthroplasty
- 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.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2008
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00134524
Start Date
July 1 2005
End Date
January 1 2008
Last Update
July 10 2007
Active Locations (5)
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1
AMRI Arizona
Tucson, Arizona, United States, 85711
2
AMRI MI
Sterling Heights, Michigan, United States, 48313
3
AMRI NC
Mocksville, North Carolina, United States, 27208
4
Amri NW Oh
Toledo, Ohio, United States, 48313