Diabetic Peripheral NeuropathyNCT04000867
Treatment for Foot Pain Caused by Diabetic Neuropathy Using Recurrent TransCutaneous Magnetic Stimulation (TCMS)
A study testing Transcutaneous Magnetic Stimulation (TCMS) in people with Diabetic Peripheral Neuropathy, run by ZyGood LLC.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- Transcutaneous Magnetic Stimulation (TCMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2019to 1 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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).
- This exclusion is restricted to opioids, benzodiazepines and psychotropic.
Trial locations and contacts
No sites are listed yet.
About this study
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
Read the detailed description
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 The United States Food and Drug Administration (FDA) has approved a similar device for treatment of migraine headaches, but this type of device has not been studied for the treatment of DN. No significant adverse reactions or side effects have been reported from the use of magnetic stimulation for the headache treatment or for the treatment of foot pain for about 20 patients. Some patients who have migraine headaches or foot pain have excellent pain relief with the magnetic treatment even if they did not get pain relief using medications.
The initial safety and feasibility study did show it was both safe and effective but short term with most benefits wearing off after 1 week. Additionally in the initial study no placebo comparisons were made, therefore this study will consist of 20-blinded randomized patients. 10 will receive the TCMS treatment weekly and 10 will receive a sham treatment weekly both for 1 month.
Investigators believe that using the device weekly will relieve the foot pain caused by diabetic neuropathy over the course on 1 month compared with those receiving the sham treatment.
And to prove this hypothesis investigators will treat 10-blinded patients in the TCMS treatment group, they will be receiving active treatment as follows:
50 pulses to the sole of the patient's left (L) foot by placing the foot on top of the device with the heel touching the heel stop (the rear position)
Then followed by another 50 pulses to sole of the patient's L foot by either:
Moving the foot forward so the toes touch the toe stop (the forward position) or By placing the patients' foot under the pulsing deck (the under-deck position)
This procedure will then be repeated for the right (R) foot
10-blinded patients in the sham treatment group will use the same device. However, device will be switched into sham mode by the only un-blinded clinician in the study 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.
Patients will receive the sham treatment the same as the TCMS treatment group, as described above and both groups will be completing a daily diary to rate and evaluate their pain and their quality of life for the month they participate in the study.
One side effect of this treatment may be some muscular jerking of the foot or the toes during the application of the magnetic pulses. This jerking will last only during the treatment and will not be painful or harmful.
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- Transcutaneous Magnetic Stimulation (TCMS)
- Keywords
- diabetic foot pain, diabetic foot neuropathy, diabetic foot numbness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Transcutaneous Magnetic Stimulation (TCMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 day +/- 2 days
Secondary outcomes (2)
Pain reduction with in the first week
Secondary endpoints will include a responder analysis in which the percentage of subjects between the sham and test groups that achieve the minimum clinically important pain reduction of 2 or more points from the scale described above within the first week of treatment.
Measured: 1 week
Improved Activities of daily living
Secondary endpoints will also include improved quality of life (ie, 1-Did the level of your pain interfere with your daily activities at home or work? 2-Did the level of your pain interfere with your social or recreational activities? 3-Did the level of your pain interfere with your sleep?) the responses as guided by the PROMIS questions ( answered as one of 5 choices Not at All A little bit Somewhat Quite a bit Very Much) included in the pre and post questionnaires and the home assessment diary booklet.
Measured: 28 days +/- 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start1 Aug 2019 (estimated)
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-site double blinded randomized control clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ZyGood LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Maryland, Kaiser Permanente
- Responsible party
- Sponsor
- Investigators
- Kashif Munir, MD, Principal investigator, University of MarylandEjaz Shamim, MD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04000867
- Sponsor's protocol ID
- TCMS for DN
- Status last verified
- Jun 2019
- First submitted
- 19 Jun 2019
- Last updated
- 27 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: not yet decided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment for Foot Pain Caused by Diabetic Neuropathy Using Recurrent TransCutaneous Magnetic Stimulation (TCMS)
- ClinicalTrials.gov ID
- NCT04000867
- Acronym / sponsor ID
- TCMS for DN
- Conditions
- Diabetic Peripheral Neuropathy
- Keywords
- diabetic foot pain, diabetic foot neuropathy, diabetic foot numbness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- ZyGood LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of Maryland, Kaiser Permanente
- Study start
- 1 Aug 2019 (estimated)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Feb 2020 (estimated)
- First posted
- 27 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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 The United States Food and Drug Administration (FDA) has approved a similar device for treatment of migraine headaches, but this type of device has not been studied for the treatment of DN. No significant adverse reactions or side effects have been reported from the use of magnetic stimulation for the headache treatment or for the treatment of foot pain for about 20 patients. Some patients who have migraine headaches or foot pain have excellent pain relief with the magnetic treatment even if they did not get pain relief using medications.
The initial safety and feasibility study did show it was both safe and effective but short term with most benefits wearing off after 1 week. Additionally in the initial study no placebo comparisons were made, therefore this study will consist of 20-blinded randomized patients. 10 will receive the TCMS treatment weekly and 10 will receive a sham treatment weekly both for 1 month.
Investigators believe that using the device weekly will relieve the foot pain caused by diabetic neuropathy over the course on 1 month compared with those receiving the sham treatment.
And to prove this hypothesis investigators will treat 10-blinded patients in the TCMS treatment group, they will be receiving active treatment as follows:
50 pulses to the sole of the patient's left (L) foot by placing the foot on top of the device with the heel touching the heel stop (the rear position)
Then followed by another 50 pulses to sole of the patient's L foot by either:
Moving the foot forward so the toes touch the toe stop (the forward position) or By placing the patients' foot under the pulsing deck (the under-deck position)
This procedure will then be repeated for the right (R) foot
10-blinded patients in the sham treatment group will use the same device. However, device will be switched into sham mode by the only un-blinded clinician in the study 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.
Patients will receive the sham treatment the same as the TCMS treatment group, as described above and both groups will be completing a daily diary to rate and evaluate their pain and their quality of life for the month they participate in the study.
One side effect of this treatment may be some muscular jerking of the foot or the toes during the application of the magnetic pulses. This jerking will last only during the treatment and will not be painful or harmful.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Multi-site double blinded randomized control clinical trial
| Arm | Type | Receives |
|---|---|---|
| real TCMS treatment | Active comparator | Device: Transcutaneous Magnetic Stimulation (TCMS)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. |
| Sham TCMS treatment | Sham comparator | Device: Transcutaneous Magnetic Stimulation (TCMS)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Sham TCMS treatment, real TCMS treatment |
Primary outcome
Overall Pain reduction
Time frame: 28 day +/- 2 days
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.
2 secondary outcomes
Pain reduction with in the first week
Time frame: 1 week
Improved Activities of daily living
Time frame: 28 days +/- 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
- Individual participant dataSharing planned: Undecided. not yet decided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kashif Munir, MD principal investigator
University of Maryland
Ejaz Shamim, MD principal investigator
Kaiser Permanente
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Magnetic Stimulation (TCMS) in people with Diabetic Peripheral Neuropathy, run by ZyGood LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leigh Vinocur, MD (410-207-6083, leigh.vinocur@zygoodhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Pain reduction (time frame: 28 day +/- 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2019.