Ignite Creation Date:
2024-05-06 @ 1:22 PM
Last Modification Date:
2024-10-26 @ 1:12 PM
Study NCT ID:
NCT04000867
Status:
UNKNOWN
Last Update Posted:
2019-06-27
First Post:
2019-06-19
Brief Title:
Treatment for Foot Pain Caused by Diabetic Neuropathy Using Recurrent TransCutaneous Magnetic Stimulation TCMS
Sponsor:
ZyGood LLC
Organization:
ZyGood LLC
Study Overview
Official Title:
Treatment for Foot Pain Caused by Diabetic Neuropathy Using Recurrent TransCutaneous Magnetic Stimulation TCMS
Status:
UNKNOWN
Status Verified Date:
2019-06
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 patients 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 patients 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
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 patients 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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None