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 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT03755960
Eligibility Criteria:
Inclusion Criteria, among others:
* Diagnosis of diabetic peripheral neuropathy in diabetes mellitus Type 2
* Males and females aged \>18yrs \< 70yrs
* Minimum overall complaints of minimum 40mm on a visual analogue scale (VAS)
* Completed titration of pain medication against diabetic peripheral neuropathy
* Pathological nerve conduction velocity and amplitude of N. suralis ( \<42meter/second and or \< 6 mikroVolt)
Exclusion Criteria, among others:
* Very severe diabetic peripheral neuropathy with muscular weakness of proximal leg muscles
* Neuropathy due to other reasons such as borrelia infection, HIV, hereditary, alcohol toxic, or related to history of neurotoxic drugs.
* Severe peripheral artery disease Fontaine stage IV
* Ulcers or gangrenous lesions of the feet
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03755960
Study Brief:
Protocol Section:
NCT03755960