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

NCT04000867 | Unknown DMC FDA Device

• 1 other identifier: TCMS for DN
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

diabetic foot pain; diabetic foot neuropathy; diabetic foot numbness

Outcome Measures

Primary Outcomes (1)

• Overall Pain reduction

  The primary endpoint will be defined as achieving at least reduction in average pain score from 0-10 (0 being no pain and 10 being the worst pain imaginable) )versus the sham control using pre-study average baseline for each subject as a covariate by a repeated measures analysis of pain scores through 28 days.

  28 day +/- 2 days

Secondary Outcomes (2)

• Pain reduction with in the first week

  1 week

• Improved Activities of daily living

  28 days +/- 2 days

Study Arms (2)

real TCMS treatment

ACTIVE COMPARATOR

Subjects with DN located in their bilateral feet that have been previously identified and have a graded average baseline score of at least 5 in each foot will receive either TCMS treatment or Sham treatment on clinic day-1 according to the contents of a sealed opaque envelope corresponding to the subject's number in the series and opened immediately before treatment on day 1. (Our statistician will have generated these envelopes and their contents in advance.) Subjects and staff evaluating the subject's response will remain blinded to treatment assignment; only the staff member setting the treatment mode will know whether it is active or sham.

Device: Transcutaneous Magnetic Stimulation (TCMS)

Sham TCMS treatment

SHAM COMPARATOR

Patients in the sham treatment group, will use the same device. The device will be switched into sham mode by the clinician by pressing a small, non-descript button on the backside of the pulse generator. The treatment device in sham mode will produce a clicking sound once every 6 seconds like the TCMS treatment mode, but no magnetic pulses will be output.

Device: Transcutaneous Magnetic Stimulation (TCMS)

Interventions

Transcutaneous Magnetic Stimulation (TCMS) DEVICE

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.

Sham TCMS treatment; real TCMS treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years of age.
• Pain duration of more than one month.
• Pain occurs daily.
• Chronic DN associated bilateral foot pain and is not explained by a central anatomic nerve compression and can clearly be correlated with that patient's history of diabetes.
• Average Pain intensity ≥ 5 in each foot for at least 3 days at the time of enrollment.

You may not qualify if:

• Life expectancy ≤ 6 months.
• Oral pain medication doses or active ingredient has changed significantly\* in the prior 2 weeks.
• Inability to walk at least 10 steps (with or without a cane/walker) before and after having to sit in a chair.
• Another pain condition that might confound results (e.g., neuropathy from cancer chemotherapy, plantar fasciitis or arthritis of ankle and foot)
• Inability to undergo study assessments or complete questionnaires independently.
• Active psychological co-morbidities (i.e., uncontrolled schizophrenia).
• Currently using an opioid medication for the treatment of foot pain\*\*.
• Pregnancy
• Inability to have MRI
• Metal hardware and/or fragments in feet and ankles
• Implanted pacemaker or a defibrillator, unless the device is considered MRI safe
• A significant change for this study is defined as a 20% increase or decrease in dosing of the patient's medication dose and/or or a change in the medication class (adding or removing other types of medicines used to treat pain).

Sponsors & Collaborators

• ZyGood LLC: lead
• University of Maryland: collaborator
• Kaiser Permanente: collaborator

Study Officials

• Kashif Munir, MD

  University of Maryland

  PRINCIPAL INVESTIGATOR

• Ejaz Shamim, MD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leigh Vinocur, MD

CONTACT

410-207-6083; leigh.vinocur@zygoodhealth.com

Steve Kaye, MS

CONTACT

443-900-3097; Steve.kaye@zygoodhealth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 20 patients given the choice of 1 out of 20 envelopes they pick, 10 will be randomized to either the real TCMS treatment arm or 10 to the sham treatment arm
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multi-site double blinded randomized control clinical trial

Study Record Dates

• First Submitted: June 19, 2019
• First Posted: June 27, 2019
• Study Start: August 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: February 1, 2020
• Last Updated: June 27, 2019

Record last verified: 2019-06