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 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT02209051
Eligibility Criteria:
Inclusion Criteria:
1. an ambulatory person at least 18 years of age at the time of informed consent.
2. type 1 or type 2 diabetes mellitus.
3. glycosylated hemoglobin (HbA1c) of ≤12%
4. at least one wound that is/has:
* Wagner grade 1 or superficial 2 (without bone, tendon or joint exposure),
* duration of at least 1 month,
* no clinical signs of infection or osteomyelitis,
* between 1cm2 and 25cm2 in area,
* per original protocol, closed \<20% in area during the Screening Period; per Amendment #1, closed \<30% in area during Screening and
* located on the foot, distal to malleoli.
5. adequate circulation to the affected extremity
6. serum creatinine of \<3.0mg/dl.
Exclusion Criteria:
1. participated in another clinical trial within 30 days prior to consent,
2. Active Charcot deformity of the study foot (i.e. erythematous, warm, edematous and actively remodeling)
3. receiving radiation or chemotherapy of any kind,
4. known or suspected malignancy of current ulcer,
5. pregnant or breast feeding,
6. an active malignant disease,
7. receiving hemo- or peritoneal dialysis,
8. sickle cell anemia or Raynaud's syndrome,
9. diagnosis of autoimmune connective tissue disease,
10. received a biologic agent, growth factor, xenograft or skin equivalent in the 30 days prior to consent,
11. exposed bone, tendon or joint capsule in the study ulcer,
12. currently receiving antibiotics (for any reason), or
13. taking medications considered to be immune system modulators.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02209051
Study Brief:
Protocol Section:
NCT02209051