Bi-Axial Rotating Magnetic Field Therapy in Refractory Ne... | NCT00123136

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

NCT00123136

Sponsor

Weintraub, Michael I., MD, FACP, FAAN

Status

Unknown status

Last Update Posted

Jul 4, 2006Estimated

Enrollment

250

Phase

Phase 4

Conditions

Diabetic Neuropathies

Interventions

foot energizer

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2005

Primary Completion Date

Not provided

Completion Date

Dec 2006

First Submitted Date

Jul 20, 2005

First Submission Date that Met QC Criteria

Jul 20, 2005

First Posted Date

Jul 22, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 28, 2006

Last Update Posted Date

Jul 4, 2006Estimated

Name	Class
Nu-Magnetics Inc.	INDUSTRY

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

250

Name	Type	Description	Arm Group Labels	Other Names
foot energizer	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
reduction of neuropathic foot pain
improve quality of life

Secondary Outcomes

Measure	Description	Time Frame
serial changes in EDX, QST, autonomic functions, biopsy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

DPN stage 2 and 3; symptomatic > 6 months

Exclusion Criteria:

Pacemaker in patient or mate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Michael I. Weintraub, MD	Contact	914-941-0788		miwneuro@pol.net

Overall Officials

Name	Affiliation	Role
Michael Weintraub, MD	New York Medical College	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Michael I. Weintraub MD 325 S. Highland Avenue	Recruiting	Briarcliff	New York	10510	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19577022	Derived	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.

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D048909	Diabetes Complications