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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2006 by Weintraub, Michael I., MD, FACP, FAAN.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Nu-Magnetics Inc.
Information provided by:
Weintraub, Michael I., MD, FACP, FAAN
ClinicalTrials.gov Identifier:
NCT00123136
First received: July 20, 2005
Last updated: June 28, 2006
Last verified: June 2006
History of Changes
  Purpose

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 Intervention Phase
Diabetic Neuropathies
 Device: foot energizer
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Weintraub, Michael I., MD, FACP, FAAN:

Primary Outcome Measures:
  • reduction of neuropathic foot pain
  • improve quality of life

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

Estimated Enrollment: 250
Study Start Date: August 2005
Estimated Study Completion Date: December 2006
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • DPN stage 2 and 3; symptomatic > 6 months

Exclusion Criteria:

  • Pacemaker in patient or mate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Weintraub, Michael I., MD, FACP, FAAN

Additional 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
Study First Received: July 20, 2005
Last Updated: June 28, 2006
Health Authority: United States: Institutional Review Board

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:
Diabetic Neuropathies
Peripheral Nervous System Diseases
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Neuromuscular Diseases
 Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on May 22, 2013