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 @ 10:56 PM
Ignite Modification Date:
2025-12-24 @ 10:56 PM
NCT ID:
NCT01427569
Eligibility Criteria:
Inclusion Criteria:
* Current diagnosis of diabetes mellitus type 1 or 2
* Foot ulcer Wagner grade 1 or 2
* Ulcer between 1 square cm and 8 square cm present for at least 60 days and not more than two years
* HgbA1C less than 10%
* Able to comply with all procedures
Exclusion Criteria:
* Wound area decrease of greater than 30% between screening and baseline visits
* Gangrene on any part of the affected foot
* Pregnancy or lactation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01427569
Study Brief:
Protocol Section:
NCT01427569