The Effects of the Magnetic Molecular Energizer (MME) on Diabetic Peripheral Neuropathy
A Randomized, Sham-Controlled Clinical Study to Evaluate The Effect of the Magnetic Molecular Energizer (MME) on Diabetic Peripheral Neuropathy
1 other identifier
interventional
100
1 country
5
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 create a clinically meaningful improvement in pain and nerve dysfunction in the feet of patients with diabetic peripheral neuropathy (DPN).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2005
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 22, 2005
CompletedFirst Posted
Study publicly available on registry
August 25, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedJuly 10, 2007
July 1, 2007
August 22, 2005
July 8, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Improvement in neurologic function following procedure
Improvement in DPN related pain following procedure
Subject tolerance to the MME procedure
Secondary Outcomes (3)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
AMRI Arizona
Tucson, Arizona, 85711, United States
AMRI MI
Sterling Heights, Michigan, 48313, United States
AMRI NC
Mocksville, North Carolina, 27208, United States
Amri NW Oh
Toledo, Ohio, 48313, United States
AMRI WA
Renton, Washington, 98055, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Wayne R Bonlie, MD
AMRI International
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 22, 2005
First Posted
August 25, 2005
Study Start
July 1, 2005
Study Completion
January 1, 2008
Last Updated
July 10, 2007
Record last verified: 2007-07