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:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-24 @ 2:55 PM
NCT ID:
NCT05831059
Eligibility Criteria:
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;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT05831059
Study Brief:
Protocol Section:
NCT05831059