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 @ 10:53 PM
Ignite Modification Date:
2025-12-24 @ 10:53 PM
NCT ID:
NCT02107469
Eligibility Criteria:
Inclusion Criteria:
* Signed consent form
* positive history of type 1 or 2 diabetes mellitus having the symptoms of diabetic neuropathy (sensory, peripheral) will be selected.
* Only outpatient setting will be included.
* Patients with ≥2 symptoms having at least one symptom with moderate severity in occasional frequency (3 points in NTSS-6) are included if they additionally show an impaired vibration detection threshold.
Exclusion Criteria:
* suffering from any other associated clinical conditions influencing peripheral nerve function, for example:
* peripheral vascular disease if reason for nerve damage
* vitamin deficiency (FOL,B12,E)
* heavy metal intoxication (especially with lead, cadmium and thallium)
* other intoxications (alcohol, medicine)
* infectious disease (like HIV, typhus, syphilis, lyme disease, mononucleosis,...)
* cancer
* autoimmune disease
* hepatitis
* vasculitis
* amyloidosis
* severe kidney failure
* pregnancy
* disorder of connective tissue
* steroids taken up to 1 month prior to study
* the likely need for insulin therapy
Regarding prior medication patients are advised not to start additional therapy during the study as long as symptoms are not worsening, antihyperglycaemic drugs will only be adjusted by study physicians if necessary.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
80 Years
Study:
NCT02107469
Study Brief:
Protocol Section:
NCT02107469