Diabetic Foot
Conditions
Brief summary
The Sham Operation Group was used as control, the patients were assessed with the Digital Rating Scale (NRS) , the quality of life-related scale (Euro Qol) , clinical outcome measures: physician's overall impression of changes in pain (CGIC) and patient's overall impression change scale (PGIC) , skin temperature measurement, toe Oxygenation measurement, and anxiety and depression scores (Gad-7, Phq-9) , objective: to evaluate the efficacy and safety of high voltage pulsed radiofrequency in the treatment of peripheral neuralgia in patients with diabetic foot.
Interventions
OTHERsham operation
The means to achieve double-blind treatment had no practical effect on the subjects
RADIATIONPulsed radio frequency therapy
Pulse Radio Frequency mode is a high voltage and low temperature Radio Frequency mode formed by discontinuous and pulsed current around nerve tissue
Sponsors
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Subjects voluntarily participate in the study and sign the informed consent form; * The age is between 18 (inclusive) and 85 (inclusive), regardless of gender; * Body mass index (BMI) ≤ 45; * Clinically diagnosed diabetes foot with moderate and severe pain in peripheral nerve of affected limb (defined as NRS score ≥ 4), the course of disease lasts for more than 12 months, and has been treated with clinical routine standard drugs (mecobalamin α- Lipoic acid, sodium valproate, carbamazepine, gabapentin/pregabalin, etc.) symptoms still exist at least 6 months later; * Glycated hemoglobin\<8%; * Not participating in the drug/medical device test within 3 months before the test;
Exclusion criteria
* Patients who are in poor condition and cannot objectively describe symptoms or cooperate to complete the questionnaire score * Ulcer is red and swollen, or active inflammatory infection; * The affected limb has lesions such as blackening and gangrene of the toe skin; * Those suffering from severe respiratory and cardiovascular diseases, liver and kidney insufficiency, and malignant tumors; * Breast-feeding and pregnant women, or subjects with pregnancy plan within 1 month after the trial (also including male subjects); * The daily dose of opioids is more than 120mg (different drug doses are converted into 120mg morphine sustained-release tablets); * People with allergic diseases and allergic constitution; * Have a history of drug abuse or drug addiction; * There are contraindications to pulsed radio frequency therapy;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale | up to 4 months | Numeric Rating Scale is the most widely used one-dimensional assessment scale，The higher the number, the more severe the pain |
Countries
China
Outcome results
None listed