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 @ 2:52 AM
Ignite Modification Date:
2025-12-25 @ 2:52 AM
NCT ID:
NCT01270633
Eligibility Criteria:
Inclusion Criteria:
* Men or women ≥ 18 years of age and able to give their own consent
* Type I or Type II diabetes with investigator-confirmed reasonable metabolic control
* Study ulcer has a Wagner grade of 1 or 2
* Study ulcer size of at least 1 cm2, but not exceeding 20 cm2 in area after debridement
* A full thickness diabetic foot ulcer located on the foot or ankle
* An ulcer which has been in existence for a minimum of 30 days, prior to the day of screening.
Exclusion Criteria:
* Suspected or confirmed signs/symptoms of wound infection
* Wounds with exposed bone or tendon
* Hypersensitivity to bovine collagen
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01270633
Study Brief:
Protocol Section:
NCT01270633