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 @ 7:11 PM
Ignite Modification Date:
2025-12-24 @ 7:11 PM
NCT ID:
NCT02363803
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥18;
2. Diagnosis of Diabetes Mellitus (Fasting Plasma Glucose \> 126 mg/dL and/or HbA1C \>6.5%);
3. Distal symmetric pain in lower extremities with duration of more than 3 months;
4. Presence of either numbness or at least 1 sensory disturbance (increased or decreased sensitivity) in the feet.
5. Spontaneous pain with intensity of ≥ 4 on 0-10 Numerical Rating Scale (NRS).
Exclusion Criteria:
1. Not giving consent to participate in the study;
2. Unable to complete self-report pain questionnaire;
3. History of moderate to severe renal or liver failure;
4. History of other central or peripheral neurologic disorders;
5. History of cardiac arrhythmias;
6. Contraindication to intravenous lidocaine;
7. Pregnancy or lactation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02363803
Study Brief:
Protocol Section:
NCT02363803