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Search / Trial NCT07078058

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

Launched by HORUS UNIVERSITY · Jul 12, 2025

Trial Information

Current as of July 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at two different treatments—low-level laser therapy and a technique called transcutaneous vagus nerve stimulation—to see how they affect blood flow changes in people with diabetic peripheral neuropathy. Diabetic peripheral neuropathy is a common problem in diabetes where nerves, especially in the legs, get damaged and cause symptoms like burning pain and tingling. The goal is to find out which treatment might better help improve blood vessel health in these patients.

The study plans to include 30 adults between 45 and 60 years old who have had diabetes for at least 5 to 10 years and are experiencing painful nerve symptoms in both legs for more than six months. Participants need to be able to walk on their own and have their diabetes well-controlled with specific blood sugar levels. People with certain heart conditions, other serious illnesses, or previous surgeries affecting nerves in the legs or back won’t be eligible. If you join the trial, you can expect to receive one of the two treatments, and the researchers will monitor how your blood vessels respond. This study is not yet recruiting participants, but it may offer new insights into managing diabetic nerve pain and improving circulation.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • The patient selection will be according to the following criteria:
  • 1. 30 patients diagnosed with diabetic neuropathy from both genders their ages will be ranged from 45-60 years old.
  • 2. All patients are ambulant independently.
  • 3. All patients are under full medical control
  • 4. Glycated hemoglobin is ranged from 6.5: 7 %.
  • 5. Patients have had diabetes for more than 5 or 10 years.
  • 6. 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.
  • 7 Neurological examination revealed abnormal sensation appeared at the ends of the extremities.
  • Exclusion Criteria:
  • 1. 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).
  • 2. Following the implantation of cardiac pacemakers or other electrical stimulation devices.
  • 3. Patient had sinus bradycardia, long QT syndrome, or other arrhythmias or mental disorders.
  • 4. Patients whose heart rate dropped below 50 beats/min after vagus nerve stimulation.
  • 5. Nerve damage as a result of prior reconstructive or replacement knee surgery, back surgery, spinal stenosis, spinal compression or radiculopathy

About Horus University

Horus University is a leading academic institution dedicated to advancing medical research and education. With a commitment to innovative healthcare solutions, the university actively sponsors clinical trials that aim to enhance treatment methodologies and patient outcomes. By fostering collaboration between researchers, clinicians, and industry partners, Horus University leverages its expertise and resources to conduct rigorous, ethically sound studies that contribute to the scientific community and improve healthcare practices globally.

Locations

Damietta, , Egypt

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported