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 @ 4:59 PM
Ignite Modification Date:
2025-12-24 @ 4:59 PM
NCT ID:
NCT01086150
Eligibility Criteria:
Inclusion Criteria:
* Group 1: 18-70 years of age, non-diabetic with no nervous system disease (healthy control group)
* Group 2: 18-70 years of age with Type I or Type II diabetes with significantly painful diabetic neuropathy (VAS \> 40mm at Baseline)
* Group 3: 18-70 years of age with Type I or Type II diabetes with non- painful or insignificantly painful diabetic neuropathy (VAS \< 40mm at Baseline)
Exclusion Criteria:
* History of clinically significant liver disease, serious peripheral vascular disease, a blood clotting disorder, or any other medical condition felt to be exclusionary by the investigator
* Allergy to lidocaine
* Unwillingness to sign informed consent or any other reasons for which the investigator feels the subject cannot complete the study
* Women who are pregnant, breastfeeding or trying to become pregnant
* History of slow-healing diabetic foot ulcers
* Current skin or soft tissue lesions on the foot that will interfere with application of the lidocaine patch and or skin biopsies
* Subjects taking Class I antiarrhythmics
* HgA1c \> 11%
* Active cancer within the previous two years except treated basal cell carcinoma of the skin
* Co-morbidities that can produce neuropathy
* Subjects taking sodium channel blockers within one week of study treatment and throughout the study
* Subjects taking any other experimental drugs within 30 days prior to Screening Visit (Visit 1)
* Application of lidocaine patch to either foot within two weeks of Screening Visit (Visit 1)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01086150
Study Brief:
Protocol Section:
NCT01086150