Low Level Laser VS Transcutaneous Vagus Nerve Stimulation on Vascular Changes in Patients With Diabetic Polyneuropathy

NCT07078058 | Not Yet Recruiting

• 1 other identifier: Manar-005515
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the effect of both low-level laser versus transcutaneous vagus nerve stimulation on vascular changes in patients with diabetic polyneuropathy

Conditions

Low Level Laser; Transcutaneous Vagus Nerve Stimulation; Diabetic Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• assessment of change of vascular blood flow

  The study uses Duplex Doppler ultrasound to assess vascular changes in the posterior tibial, anterior tibial, and peroneal arteries, assessing blood flow, Tunica intima thickness, and Resistive index using a variable frequency range.

  at baseline and after 8 weeks

Secondary Outcomes (2)

• Assessment of change of Neuropathic Pain

  at baseline and after 8 weeks

• Assessment of change of Quality of life

  at baseline and after 8 weeks

Study Arms (2)

Low Level Laser

EXPERIMENTAL

Patients will receive Low Level Laser irradiated with two wavelengths of visible 630 nm and near infra-red 810 nm for 15 min on entire surface of each foot three times a week for 2 months

Device: Low level laser

Transcutaneous auricular Vagus nerve stimulation

ACTIVE COMPARATOR

Patients will receive 30 minutes Transcutaneous auricular Vagus nerve stimulation 5 sessions per week for 2 months.

Device: Transcutaneous auricular Vagus nerve stimulation

Interventions

Low level laser DEVICE

Patients in the low level laser group will be irradiated with visible and near-infra-red lasers at a pulsed mode with a frequency of 35 Hz, peak power of 100 mW, and a spot diameter of 5 mm. The 15-minute sessions were performed three times a week for two months, with each laser having a power density of 0.35 mW/cm2 and an energy density of 32.08 J/cm2.

Low Level Laser

Transcutaneous auricular Vagus nerve stimulation DEVICE

Patients will receive 30 minutes of transcutaneous vagus nerve stimulation for 2 months, with 5 sessions per week. The antihelix and cymba concha will be sterilized with 75% alcohol, and the electrode will be attached. The device parameters include a wave width of 0.2 ms ± 30%, pulse frequency of 20 Hz, gradually increasing intensity to a tolerable intensity (4-6 mA), and duration of 30 minutes.

Transcutaneous auricular Vagus nerve stimulation

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The patient selection will be according to the following criteria:
• patients diagnosed with diabetic neuropathy from both genders their ages will be ranged from 45-60 years old.
• All patients are ambulant independently.
• All patients are under full medical control
• Glycated hemoglobin is ranged from 6.5: 7 %.
• Patients have had diabetes for more than 5 or 10 years.
• patients experiencing painful peripheral neuropathic symptoms for more than 6 months involving both lower extremities and complained of burning pain with paresthesia in both legs.
• Neurological examination revealed abnormal sensation appeared at the ends of the extremities.

You may not qualify if:

• Patients had unstable glycemic control and/or medical conditions that would confound assessment of neuropathy such as malignancy, active/untreated thyroid disease, peripheral vascular diseases, vascular insufficiency (claudication, skin discoloration, ulceration).
• Following the implantation of cardiac pacemakers or other electrical stimulation devices.
• Patient had sinus bradycardia, long QT syndrome, or other arrhythmias or mental disorders.
• Patients whose heart rate dropped below 50 beats/min after vagus nerve stimulation.
• Nerve damage as a result of prior reconstructive or replacement knee surgery, back surgery, spinal stenosis, spinal compression or radiculopathy

Sponsors & Collaborators

• Horus University: lead

Study Sites (1)

out-patient clinic, faculty of physical therapy, Horus university

Damietta, Egypt

Location

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Central Study Contacts

Manar Elbaz Mohamed nasr, Assistant lecturer

CONTACT

01008805149; melbaz@horus.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 12, 2025
• First Posted: July 22, 2025
• Study Start: August 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)