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 @ 4:18 PM
Ignite Modification Date:
2025-12-24 @ 4:18 PM
NCT ID:
NCT00753766
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of diabetes mellitus
* A1c 7.5%,
* Scheduled elective vascular surgery that may be safely deferred for 6 weeks
* Surgeon's approval to participate
Exclusion Criteria:
* Hemoglobin A1c \>14% (This criterion was included since, once identified, such a patient warrants improved glucose control and can not be ethically entered into a trial where there is a 50% chance of being assigned to usual care)
* Myocardial infarction in prior 6 months
* Cerebrovascular disease in prior 6 months
* Active cancer requiring ongoing treatment
* Severe psychiatric disease limiting ability to comply with protocol
* Unable to attend follow up appointments
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00753766
Study Brief:
Protocol Section:
NCT00753766