Ignite Creation Date:
2024-05-06 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 12:49 PM
Study NCT ID:
NCT03596203
Status:
COMPLETED
Last Update Posted:
2022-03-04
First Post:
2018-07-03
Brief Title:
TCMS for the Treatment of Foot Pain Caused By Diabetic Neuropathy
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
TransCutaneous Magnetic Stimulation TCMS for the Treatment of Foot Pain Caused By Diabetic Neuropathy
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
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 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
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 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 Some patients who have migraine headaches have excellent pain relief with the magnetic treatment even if they did not get pain relief using medications
The investigators do not know whether this magnetic treatment will relieve the foot pain caused by diabetic neuropathy so they will test this by applying 50 strong magnet pulses to the painful area of each foot This procedure will be repeated onto three parts of each foot First onto the bottom of the foot then the top of the foot and then the back of the foot including a portion of the ankle The effect on pain in each foot while walking for about 10 steps will be recorded before the study begins and periodically for 28 days This testing will provide data as to any improvement in pain relief If the participants reported pain is reduced as a result of the magnetic treatment then the magnetic pulses will have shown that they have reduced the pain Additional studies will be needed to further investigate this treatment and to determine how to obtain statistically significant data as to whether this therapy reduces the foot pain caused by diabetic neuropathy
One side effect of this treatment may be some muscular jerking of the foot or the leg during the application of the magnetic pulses This jerking will last only during the treatment and will not be painful or harmful
The investigators do not know whether this magnetic treatment will relieve the foot pain caused by diabetic neuropathy so they will test this by applying 50 strong magnet pulses to the painful area of each foot This procedure will be repeated onto three parts of each foot First onto the bottom of the foot then the top of the foot and then the back of the foot including a portion of the ankle The effect on pain in each foot while walking for about 10 steps will be recorded before the study begins and periodically for 28 days This testing will provide data as to any improvement in pain relief If the participants reported pain is reduced as a result of the magnetic treatment then the magnetic pulses will have shown that they have reduced the pain Additional studies will be needed to further investigate this treatment and to determine how to obtain statistically significant data as to whether this therapy reduces the foot pain caused by diabetic neuropathy
One side effect of this treatment may be some muscular jerking of the foot or the leg 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?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None