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 @ 11:45 AM
Ignite Modification Date:
2025-12-24 @ 11:45 AM
NCT ID:
NCT02402361
Eligibility Criteria:
Inclusion Criteria:
* Patients with diabetes who are ≥18 years of age who have a diagnosis of peripheral neuropathy based on a prior clinical assessment combined with supportive clinical investigations such as abnormal nerve conduction studies, reduced intraepidermal nerve or abnormal findings on quantitative sensory testing.
* If supportive clinical investigations (as described above) are not available at entry into the study, a neuropathy disability scale ≥3 will be required.
* Patients with symptoms highly suggestive of neuropathy that in the judgment of the clinical researcher are suitable for the study even if they do not fulfill other inclusion criteria.
Exclusion Criteria:
* Subjects who are pregnant.
* Subjects with insufficient command of Hebrew to obtain consent from or to complete the study questionnaires.
* Subjects with insufficient mental capacity to obtain consent from or complete study questionnaires.
* Subjects with concurrent severe psychological or psychiatric disorders.
* Patients with moderate to severe pain form other causes that may confound assessment or reporting of pain.
* Patients with central nervous lesions, which may complicate somatosensory testing.
* Who is in the opinion of the investigator unsuitable for participation in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02402361
Study Brief:
Protocol Section:
NCT02402361