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

First Received on July 20, 2005. Last Updated on June 28, 2006 History of Changes

Sponsor:	Weintraub, Michael I., MD, FACP, FAAN
Collaborator:	Nu-Magnetics Inc.
Information provided by:	Weintraub, Michael I., MD, FACP, FAAN
ClinicalTrials.gov Identifier:	NCT00123136

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 IV

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus Charcot-Marie-Tooth disease hereditary neuropathy with liability to pressure palsies

MedlinePlus related topics: Diabetic Nerve Problems Foot Health Peripheral Nerve Disorders

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):

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.

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 February 09, 2012