NCT00123136

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2005

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2005

Completed
10 days until next milestone

Study Start

First participant enrolled

August 1, 2005

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

July 4, 2006

Status Verified

June 1, 2006

First QC Date

July 20, 2005

Last Update Submit

June 28, 2006

Conditions

Diabetic Neuropathies

Keywords

pulsed magnetic field therapydiabetic peripheral neuropathyneuromodulationdiabetic peripheral neuropathic painsleep benefitdiabetic peripheral neuropathic functioning

Outcome Measures

Primary Outcomes (2)

  • reduction of neuropathic foot pain

  • improve quality of life

Secondary Outcomes (1)

  • serial changes in EDX, QST, autonomic functions, biopsy

Interventions

foot energizerDEVICE

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • DPN stage 2 and 3; symptomatic \> 6 months

You may not qualify if:

  • Pacemaker in patient or mate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michael I. Weintraub MD 325 S. Highland Avenue

Briarcliff, New York, 10510, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 19577022DERIVED

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Michael Weintraub, MD

    New York Medical College

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael I. Weintraub, MD

CONTACT

914-941-0788miwneuro@pol.net

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDIV

Study Record Dates

First Submitted

July 20, 2005

First Posted

July 22, 2005

Study Start

August 1, 2005

Study Completion

December 1, 2006

Last Updated

July 4, 2006

Record last verified: 2006-06

Locations

US(1)