Diabetic NeuropathiesPhase 4NCT00123136
Bi-Axial Rotating Magnetic Field Therapy in Refractory Neuropathic Foot Pain Secondary to Diabetic Peripheral Neuropathy
A Phase 4 study testing foot energizer in people with Diabetic Neuropathies, run by Weintraub, Michael I., MD, FACP, FAAN at 1 site in United States.
Trial summary
The researchers will study the application of a commercial pulsed magnetic stimulating device to the feet of patients with moderate-severe foot pain secondary to diabetic peripheral neuropathy (DPN). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetic Neuropathies
- What is being tested?
- foot energizer
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Dec 2006
- Phase
- Phase 4
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DPN stage 2 and 3; symptomatic > 6 months
Who cannot join
- Pacemaker in patient or mate
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Michael I. Weintraub MD 325 S. Highland Avenue
Briarcliff, New York, 10510
Susan Wolert, Data
About this study
Official title: Bi-Axial Rotating Magnetic Field Therapy in Refractory Neuropathic Foot Pain Secondary to Diabetic Peripheral Neuropathy. Multi-Center, Randomized Placebo Controlled Trial
The researchers will study the application of a commercial pulsed magnetic stimulating device to the feet of patients with moderate-severe foot pain secondary to diabetic peripheral neuropathy (DPN).
- Conditions
- Diabetic Neuropathies
- Being tested
- foot energizer
- Keywords
- pulsed magnetic field therapy, diabetic peripheral neuropathy, neuromodulation, diabetic peripheral neuropathic pain, sleep benefit, diabetic peripheral neuropathic functioning
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
foot energizerDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction of neuropathic foot pain
improve quality of life
Secondary outcomes (1)
serial changes in EDX, QST, autonomic functions, biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2005 (estimated)
- Study startAug 2005
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 250 participants
Sponsor and investigators
- Lead sponsor
- Weintraub, Michael I., MD, FACP, FAAN
- Collaborators
- Nu-Magnetics Inc.
- Investigators
- Michael Weintraub, MD, Principal investigator, New York Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00123136
- Sponsor's protocol ID
- 2005-81440-DPN
- Other IDs
- 2005
- Status last verified
- Jun 2006
- First submitted
- 20 Jul 2005
- Last updated
- 4 Jul 2006
- Results posted
- No
Publications
Weintraub MI, Herrmann DN, Smith AG, Backonja MM, Cole SP. Pulsed electromagnetic fields to reduce diabetic neuropathic pain and stimulate neuronal repair: a randomized controlled trial. Arch Phys Med Rehabil. 2009 Jul;90(7):1102-9. doi: 10.1016/j.apmr.2009.01.019.
PubMed 19577022
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bi-Axial Rotating Magnetic Field Therapy in Refractory Neuropathic Foot Pain Secondary to Diabetic Peripheral Neuropathy. Multi-Center, Randomized Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT00123136
- Acronym / sponsor ID
- 2005-81440-DPN
- Conditions
- Diabetic Neuropathies
- Keywords
- pulsed magnetic field therapy, diabetic peripheral neuropathy, neuromodulation, diabetic peripheral neuropathic pain, sleep benefit, diabetic peripheral neuropathic functioning
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants
- Lead sponsor
- Weintraub, Michael I., MD, FACP, FAAN
- Collaborators
- Nu-Magnetics Inc.
- Study start
- Aug 2005
- Study completion
- Dec 2006
- First posted
- 22 Jul 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.
The researchers will study the application of a commercial pulsed magnetic stimulating device to the feet of patients with moderate-severe foot pain secondary to diabetic peripheral neuropathy (DPN).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- DPN stage 2 and 3; symptomatic > 6 months
Key exclusion criteria (1 listed)
- Pacemaker in patient or mate
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 |
|---|---|---|
| foot energizer | Device | – |
Primary outcome
reduction of neuropathic foot pain
improve quality of life
1 secondary outcome
serial changes in EDX, QST, autonomic functions, biopsy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2006.
- Derived from this study: PubMed 19577022Weintraub MI, Herrmann DN, Smith AG, Backonja MM, Cole SP. Pulsed electromagnetic fields to reduce diabetic neuropathic pain and stimulate neuronal repair: a randomized controlled trial. Arch Phys Med Rehabil. 2009 Jul;90(7):1102-9. doi: 10.1016/j.apmr.2009.01.019.
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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.
Michael Weintraub, MD principal investigator
New York Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing foot energizer in people with Diabetic Neuropathies, run by Weintraub, Michael I., MD, FACP, FAAN at 1 site 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 1 inclusion and 1 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 4 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Michael I. Weintraub, MD (914-941-0788, miwneuro@pol.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction of neuropathic foot pain. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00123136, which also lists 1 linked publication.
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 4 Jul 2006.