Diabetic peripheral neuropathy
Conditions
Interventions
Sponsors
Zhongda Hospital Affiliated to Southeast University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Those who meet all the following conditions can be selected for observation: 1.Patients aged 18-75 years (inclusive) with type 2 diabetes, regardless of gender; 2.Meet the diagnostic criteria for diabetic peripheral neuropathy; 3.Have a Toronto Score (TCSS) of >= 9 points. 4.Have received medications related to diabetic peripheral neuropathy and are on a standardized treatment plan, usually requiring a drug withdrawal period of more than 1 month. After confirmation of enrollment, in principle, no additional such drugs will be added except for mecobalamin. 5.Glycated hemoglobin (HbA1c) <= 8% 6.Sign the informed consent form.
Exclusion criteria
Exclusion criteria: Any of the following conditions must be excluded: 1. Those with an implanted cardiac pacemaker or with implanted metal in their bodies (below the knee joint). 2. Those with lower limb ulcers. 3. Those with an ABI value less than 0.4. 4. Those with abnormal liver and kidney functions, or those who have been taking medications to treat abnormal liver and kidney functions for a long time. 5. Those with malignant tumors, or those who have had tumors removed but are currently undergoing chemotherapy and radiotherapy. 6. Those with drug-induced nerve damage, non-diabetic nerve lesions and injuries, or those with organic lesions related to the symptoms of this disease, including nerve lesions caused by other diseases (such as nerve root compression caused by cervical and lumbar spine lesions, spinal canal stenosis, Guillain-Barré syndrome, etc.). 7. Those with deep vein thrombosis in the lower extremities (including those with a history of thrombosis) or those with acute arterial embolism, or those with lower extremity lymphatic vessel lesions. 8. Those with congestive heart failure of grade III or above as assessed by New York Heart Function Classification. 9. Those with a history of bleeding, such as hemophilia, fragile capillaries, upper gastrointestinal bleeding, hemoptysis, stubborn gingival bleeding, etc. 10. Pregnant, lactating women, or those who plan to become pregnant during the observation period. 11. Those who have experienced myocardial infarction, cerebral infarction, or cerebral hemorrhage within 6 months before screening, or those who have abnormal results in routine examinations such as myocardial infarction quantification, electrocardiogram, cervical artery color Doppler ultrasound after admission, and which are clinically significant after assessment by the clinical physician, or those who have significant risk factors for myocardial infarction, cerebral stroke, etc. as assessed by the clinical physician. 12. Those who are currently participating in other clinical trials within 3 months before screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Toronto clinical scoring system(TCSS);Efficacy: The therapeutic effect is determined based on the Toronto score results.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Nerve conduction velocity;Efficacy evaluation: The therapeutic effect is determined based on the changes in the nerve conduction velocity of the gastrocnemius nerve;VAS Visual Analogue Scale;Vibration PerceptionThreshold;Michigan State Diabetes Peripheral Neuropathy Screening Form;Neurological symptom score; | — |
Countries
China
Contacts
Public ContactBingquan Yang
Zhongda Hospital Affiliated to Southeast University
Outcome results
None listed