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Bi-Axial Rotating Magnetic Field Therapy in Refractory Neuropathic Foot Pain Secondary to Diabetic Peripheral Neuropathy

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ClinicalTrials.gov Identifier: NCT00123136
Recruitment Status : Unknown
Verified June 2006 by Weintraub, Michael I., MD, FACP, FAAN.
Recruitment status was:  Recruiting
First Posted : July 22, 2005
Last Update Posted : July 4, 2006
Sponsor:
Collaborator:
Nu-Magnetics Inc.
Information provided by:
Weintraub, Michael I., MD, FACP, FAAN

Brief 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).

Condition or disease Intervention/treatment Phase
Diabetic Neuropathies Device: foot energizer Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Bi-Axial Rotating Magnetic Field Therapy in Refractory Neuropathic Foot Pain Secondary to Diabetic Peripheral Neuropathy. Multi-Center, Randomized Placebo Controlled Trial
Study Start Date : August 2005
Estimated Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. reduction of neuropathic foot pain
  2. improve quality of life

Secondary Outcome Measures :
  1. serial changes in EDX, QST, autonomic functions, biopsy


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • DPN stage 2 and 3; symptomatic > 6 months

Exclusion Criteria:

  • Pacemaker in patient or mate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00123136


Contacts
Contact: Michael I. Weintraub, MD 914-941-0788 miwneuro@pol.net

Locations
United States, New York
Michael I. Weintraub MD 325 S. Highland Avenue Recruiting
Briarcliff, New York, United States, 10510
Sub-Investigator: Susan Wolert, Data         
Sponsors and Collaborators
Weintraub, Michael I., MD, FACP, FAAN
Nu-Magnetics Inc.
Investigators
Principal Investigator: Michael Weintraub, MD New York Medical College

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00123136     History of Changes
Other Study ID Numbers: 2005-81440-DPN
First Posted: July 22, 2005    Key Record Dates
Last Update Posted: July 4, 2006
Last Verified: June 2006

Keywords provided by Weintraub, Michael I., MD, FACP, FAAN:
pulsed magnetic field therapy
diabetic peripheral neuropathy
neuromodulation
diabetic peripheral neuropathic pain
sleep benefit
diabetic peripheral neuropathic functioning

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases