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

Primary Purpose

Diabetic Neuropathies

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
foot energizer
Sponsored by
Weintraub, Michael I., MD, FACP, FAAN
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Neuropathies focused on measuring pulsed magnetic field therapy, diabetic peripheral neuropathy, neuromodulation, diabetic peripheral neuropathic pain, sleep benefit, diabetic peripheral neuropathic functioning

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: DPN stage 2 and 3; symptomatic > 6 months Exclusion Criteria: Pacemaker in patient or mate

Sites / Locations

  • Michael I. Weintraub MD 325 S. Highland AvenueRecruiting

Outcomes

Primary Outcome Measures

reduction of neuropathic foot pain
improve quality of life

Secondary Outcome Measures

serial changes in EDX, QST, autonomic functions, biopsy

Full Information

First Posted
July 20, 2005
Last Updated
June 28, 2006
Sponsor
Weintraub, Michael I., MD, FACP, FAAN
Collaborators
Nu-Magnetics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00123136
Brief Title
Bi-Axial Rotating Magnetic Field Therapy in Refractory Neuropathic Foot Pain Secondary to Diabetic Peripheral Neuropathy
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 Type
Interventional

2. Study Status

Record Verification Date
June 2006
Overall Recruitment Status
Unknown status
Study Start Date
August 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Weintraub, Michael I., MD, FACP, FAAN
Collaborators
Nu-Magnetics Inc.

4. Oversight

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathies
Keywords
pulsed magnetic field therapy, diabetic peripheral neuropathy, neuromodulation, diabetic peripheral neuropathic pain, sleep benefit, diabetic peripheral neuropathic functioning

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
250 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
foot energizer
Primary Outcome Measure Information:
Title
reduction of neuropathic foot pain
Title
improve quality of life
Secondary Outcome Measure Information:
Title
serial changes in EDX, QST, autonomic functions, biopsy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: DPN stage 2 and 3; symptomatic > 6 months Exclusion Criteria: Pacemaker in patient or mate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael I. Weintraub, MD
Phone
914-941-0788
Email
miwneuro@pol.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Weintraub, MD
Organizational Affiliation
New York Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michael I. Weintraub MD 325 S. Highland Avenue
City
Briarcliff
State/Province
New York
ZIP/Postal Code
10510
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Wolert, Data

12. IPD Sharing Statement

Citations:
PubMed Identifier
19577022
Citation
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.
Results Reference
derived

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

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