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

• Sponsor: Weintraub, Michael I., MD, FACP, FAAN (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00123136
• Collaborator: Nu-Magnetics Inc. (Industry)
• Enrollment: 250
• Location: 1
• Duration (Months): 16
• Patients Per Site Per Month: 15.6

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Aug 1, 2005
• Study Completion Date: Dec 1, 2006

Outcome Measures

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 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• DPN stage 2 and 3; symptomatic > 6 months

Exclusion Criteria:

• Pacemaker in patient or mate

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Michael I. Weintraub MD 325 S. Highland Avenue	Briarcliff	New York	United States	10510

Sponsors and Collaborators

• Weintraub, Michael I., MD, FACP, FAAN
• Nu-Magnetics Inc.

Investigators

• Principal Investigator: Michael Weintraub, MD, New York Medical College

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00123136
• Other Study ID Numbers: 2005-81440-DPN
• First Posted: Jul 22, 2005
• Last Update Posted: Jul 4, 2006
• Last Verified: Jun 1, 2006

• Keywords provided by , ,: 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

Study Results

No Results Posted as of Jul 4, 2006