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 @ 11:51 PM
Ignite Modification Date:
2025-12-24 @ 11:51 PM
NCT ID:
NCT00010751
Eligibility Criteria:
* NIDDM as defined by the World Health Organization
* Diagnosed with DPN +/- DAN for a duration of no less than six months
* Women of childbearing potential must be using an acceptable method of contraception to prevent pregnancy when they are enrolled in the study and must agree to continue to practice an acceptable method of contraception for the duration of their participation
* Stability of diabetes control by documentation of \<1% fluctuation of HbA1c levels over the last twelve months and 3 or less mild hypoglycemic reactions per week. All subjects must be prepared to monitor blood glucose values three to four times daily
* HbA1c should be \<10%
* Ability to give informed consent and willingness to sign the Institutional Review Board approved consent form
* Willingness to cooperate with medical therapy and follow up for the 12 months of the study duration
* Have the ability to understand English
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
80 Years
Study:
NCT00010751
Study Brief:
Protocol Section:
NCT00010751