Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-31 @ 2:42 AM
Study NCT ID:
NCT07078058
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-22
First Post:
2025-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Level Laser VS Transcutaneous Vagus Nerve Stimulation on Vascular Changes in Patients With Diabetic Polyneuropathy
Sponsor:
Horus University
Organization:
Study Overview
Official Title:
Low Level Laser Versus Transcutaneous Vagus Nerve Stimulation on Vascular Changes in Patients With Diabetic Polyneuropathy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
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:
To compare the effect of both low-level laser versus transcutaneous vagus nerve stimulation on vascular changes in patients with diabetic polyneuropathy
Detailed Description:
Diabetic polyneuropathy is a prevalent and severe diabetes-related complication linked to cardiovascular mortality and disease events, even after accounting for risk factors and diabetes status.
Diabetic polyneuropathy affects the peripheral nervous system, leading to dysfunctions in sensory, motor, and autonomic nervous systems. It predisposes diabetics to refractory neuropathic pain, foot ulcers, and amputation, lowering quality of life, increasing mortality, and prompting patients with diabetes to seek medical attention.
Over half of diabetes patients experienced painful diabetic polyneuropathy over the past few decades Painful diabetic polyneuropathy therapy uses various drugs for symptom relief, but they often have systemic side effects and do not slow neuropathy progression. Therefore, investigating non-pharmacological interventions like low-level laser and transcutaneous auricular vagus nerve stimulation is crucial for developing more effective and potentially safer pain management options.
low-level laser therapy and transcutaneous auricular vagus nerve stimulation are emerging non-invasive interventions that have shown potential in alleviating pain associated with diabetic polyneuropathy, a common diabetes complication affecting quality of life.
The effectiveness of conservative treatment options for painful diabetic polyneuropathy needs further investigation. If one method proves superior in reducing pain, improving macrovascular health, and quality of life, it could guide clinical decisions
Diabetic polyneuropathy affects the peripheral nervous system, leading to dysfunctions in sensory, motor, and autonomic nervous systems. It predisposes diabetics to refractory neuropathic pain, foot ulcers, and amputation, lowering quality of life, increasing mortality, and prompting patients with diabetes to seek medical attention.
Over half of diabetes patients experienced painful diabetic polyneuropathy over the past few decades Painful diabetic polyneuropathy therapy uses various drugs for symptom relief, but they often have systemic side effects and do not slow neuropathy progression. Therefore, investigating non-pharmacological interventions like low-level laser and transcutaneous auricular vagus nerve stimulation is crucial for developing more effective and potentially safer pain management options.
low-level laser therapy and transcutaneous auricular vagus nerve stimulation are emerging non-invasive interventions that have shown potential in alleviating pain associated with diabetic polyneuropathy, a common diabetes complication affecting quality of life.
The effectiveness of conservative treatment options for painful diabetic polyneuropathy needs further investigation. If one method proves superior in reducing pain, improving macrovascular health, and quality of life, it could guide clinical decisions
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: