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:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 12:05 AM
NCT ID:
NCT01247558
Eligibility Criteria:
Inclusion Criteria:
* Patients must have pharmacy claims for \>120 continuous days of Metanx®. This will be defined as at least a 90-day supply dispensed within the first 120 days post-index. The first pharmacy claim for Metanx® will be the index date.
* Patients must have a diagnosis of diabetes prior to or including the index date.
* Patients must have a diagnosis of a peripheral neurological or a peripheral circulation disorder.
* Patients must have a diagnosis of lower limb ulcer.
Exclusion Criteria:
* Patients will be excluded if they have \<18 months of eligibility defined as a minimum of 6 months pre and 12 months post-index eligibility.
* Patients will be excluded if they have taken other L-methylfolate containing products (Deplin®, Cerefolin®, Cerefolin NAC®,Neevo®) or other prescription folic acid combination products with \>1mg folic acid.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
80 Years
Study:
NCT01247558
Study Brief:
Protocol Section:
NCT01247558