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 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT03078933
Eligibility Criteria:
Inclusion Criteria:
* Diabetes Type 1 or Type 2
* Wound size greater than or equal to 1 cm2 and less than or equal to 16 cm2
* HbA1c less than or equal to 12 %
* Single full thickness DFU on the plantar aspect of toes or foot
* Ankle Brachial Index greater than or equal to 0.7
Exclusion Criteria:
* Infection of the ulcer
* Active Charcot's disease
* wound involves deeper tissues including bone or tendon
* Negative pressure therapy on affected foot or Hyperbaric Oxygen Therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
85 Years
Study:
NCT03078933
Study Brief:
Protocol Section:
NCT03078933