A Sympathetic Ganglion, High-voltage Pulsed Radiofrequency Ablation of Peripheral Neuralgia

Diabetic Foot Clinical Trial

Official title:

A Randomized, Controlled, Double-blind, Multicenter, Sympathetic Ganglion, High-voltage Pulsed Radiofrequency Ablation of Peripheral Neuralgia in Patients With Diabetic Foot

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05831059
• Other study ID #: XH-23-004
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 12, 2022
• Est. completion date: December 15, 2024

Study information

• Verified date: April 2024
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 15, 2024
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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 a- 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;

Related Conditions & MeSH terms

• Diabetic Foot
• Neuralgia

Intervention

Radiation:
• Pulsed 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

Other:
• sham operation
The means to achieve double-blind treatment had no practical effect on the subjects

Locations

Country	Name	City	State
China	Shanghai XINHUA Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Rating Scale	Numeric Rating Scale is the most widely used one-dimensional assessment scale,The higher the number, the more severe the pain	up to 4 months