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Treatment for Foot Pain Caused by Diabetic Neuropathy Using Recurrent TransCutaneous Magnetic Stimulation (TCMS)

NCT04000867 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-06-27

No results posted yet for this study

Summary

The study will evaluate whether an experimental medical device that emits a series of brief, intense magnetic pulse will relieve foot pain from Diabetic Neuropathy (DN) if used weekly for a month

Conditions

  • Diabetic Peripheral Neuropathy

Interventions

DEVICE

Transcutaneous Magnetic Stimulation (TCMS)

The study will evaluate whether an experimental medical device that emits a series of brief, intense magnetic pulse called TCMS will relieve foot pain from Diabetic Neuropathy (DN) when compared to the same device giving a sham treatment without magnetic pulses. Participants will be blindly randomized into either the TCMS treatment group or the sham treatment group according to the number 1-20 that they draw. This is necessary to further investigate this TCMS treatment and to determine how to obtain statistically significant data as to whether this therapy reduces the foot pain caused by diabetic neuropathy.

Sponsors & Collaborators

  • University of Maryland

    collaborator OTHER

  • Kaiser Permanente

    collaborator OTHER

  • ZyGood LLC

    lead INDUSTRY

Principal Investigators

  • Kashif Munir, MD · University of Maryland

  • Ejaz Shamim, MD · Kaiser Permanente

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2019-12-01
Completion
2020-02-01
FDA Device
Yes

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04000867 on ClinicalTrials.gov