Diabetic NeuropathiesPhase 3NCT00134524
The Effects of the Magnetic Molecular Energizer (MME) on Diabetic Peripheral Neuropathy
A Phase 3 study testing MME procedure in people with Diabetic Neuropathies and Pain, run by Advanced Magnetic Research Institute International at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Diabetic Neuropathies, Pain, Neuralgia
- What is being tested?
- MME procedure
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 5 sitesUnited States
- Study dates
- Jul 2005to Jan 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
AMRI NC
Mocksville, North Carolina, 27208
AMRI WA
Renton, Washington, 98055
AMRI MI
Sterling Heights, Michigan, 48313
Amri NW Oh
Toledo, Ohio, 48313
AMRI Arizona
Tucson, Arizona, 85711
About this study
Official title: A Randomized, Sham-Controlled Clinical Study to Evaluate The Effect of the Magnetic Molecular Energizer (MME) on Diabetic Peripheral Neuropathy
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).
Read the 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 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.
- Conditions
- Diabetic Neuropathies, Pain, Neuralgia
- Being tested
- MME procedure
- Keywords
- Magnetics, Electromagnetics, Diabetic neuropathy, Pain
- Medical subject headings
- Diabetic Neuropathies, Pain, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MME procedureProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2005 (estimated)
- Study startJul 2005
- Study completionJan 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NeuropathiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Advanced Magnetic Research Institute International
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Wayne R Bonlie, MD, Study director, AMRI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00134524
- Sponsor's protocol ID
- AMRI-DPN-01
- Status last verified
- Jul 2007
- First submitted
- 22 Aug 2005
- Last updated
- 10 Jul 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Sham-Controlled Clinical Study to Evaluate The Effect of the Magnetic Molecular Energizer (MME) on Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT00134524
- Acronym / sponsor ID
- AMRI-DPN-01
- Conditions
- Diabetic Neuropathies, Pain, Neuralgia
- Keywords
- Magnetics, Electromagnetics, Diabetic neuropathy, Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Advanced Magnetic Research Institute InternationalIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Study completion
- Jan 2008 (estimated)
- First posted
- 25 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MME procedure | Procedure or surgery | – |
Primary outcome
Improvement in neurologic function following procedure
Improvement in DPN related pain following procedure
Subject tolerance to the MME procedure
3 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2007.
- Study sponsor, AMRI International website homepageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wayne R Bonlie, MD study director
AMRI International
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MME procedure in people with Diabetic Neuropathies and Pain, run by Advanced Magnetic Research Institute International at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in neurologic function following procedure. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2007.