Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT07078058
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
60 Years
Study:
NCT07078058
Study Brief:
Protocol Section:
NCT07078058