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 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT04723134
Eligibility Criteria:
Inclusion Criteria:
* Study subjects will be male or female Veterans with T2DM managed with insulin and/or non-insulin therapy who have a chronic, non-healing DFU (wound age: at least 4-weeks) and who have signed an Institutional Review Board approved informed consent document.
* Study subject candidates (SC) - may present with multiple DFUs; however, only one DFU per SC will be selected for study. A DFU-SC must be observed with: 1) at least a four-week history of a non-healing, superficial DFU-wound; PEDIS-Grade 1 or 2 Depth (wound above fascia without exposed muscle, tendon or bone); 2) DFU-wound area between 1-12cm2; 3) DFU-wound with or without clinical neuropathy; 4) DFU-wound lower extremity non-invasive Doppler studies with ankle-brachial index value ≥0.7 and/or Toe pressure ≥50mmHg; and, 5) without evidence of acute infection (e.g., cellulitis, abscess or osteomyelitis) at the time of enrollment.
* If the subject is a woman of childbearing potential she must be practicing an acceptable form of birth control, as determined by the Investigator. All females with an intact uterus must have a negative Beta-Human Chorionic Gonadotropin test (\< 5mIU/mL) to proceed with study participation.
Exclusion Criteria:
* Any SC who is unable to provide written informed consent will not be enrolled for study participation.
* Any SC who is pregnant or breast feeding, will not be allowed to enroll, or continue, in the study, as pregnancy or breast feeding may impact the study results.
* Subjects with DFU-wounds less than 1cm-square or greater than 12cm-square will be excluded from the study.
* At the beginning of the four-week Screening Phase all SC will be scheduled for study-selected standard DFU wound treatment and off-loading of the study ulcer, as determined by the PI. Subject candidates who are unable to comply with the recommended off-loading of the selected DFU-study wound will be excluded from study.
* During the Screening Phase, any SC whose DFU wound demonstrates more than a fifty-percent (50%) reduction in wound area will be excluded from the study \[37\].
* Any SC with a current active history of alcohol or substance abuse will be excluded from study participation.
* Any SC receiving steroid therapy (prednisone), chemotherapy or biological therapies (e.g., Humira) within twelve-weeks will be excluded.
* Any SC with active cancerous lesions, with or without chemotherapy, will be excluded from study participation.
* Any SC having received hyperbaric oxygen therapy (HBOT) or the use of bioengineered skin substitutes (i.e., Dermagraft® or Apligraf®) within six-months will be excluded from study participation.
* Any SC receiving platelet-derived growth factor therapy (Regranex®, Ortho- McNeil) within six-months will be excluded from study participation.
* Any SC who is on dialysis (hemo- or peritoneal dialysis) or has end stage renal disease will be excluded from study participation.
* A SC with ABI values \<0.7 or toe pressure \<50mmHg, for the involved lower extremity of the study DFU-wound, will be excluded from study participation.
* A SC with a HgbA1C \>9 will be excluded from study participation.
* Any SC with a medical condition, which, in the opinion of the investigator should exclude him/her from participating in the study.
* Any SC previously taking daily oral high-dose folic acid with B-vitamin supplements (HDFA; folic acid-5mg/cyanocobalamin- 4mg/pyridoxine-50mg) for DFU-wound treatment will not be considered for study participation until at least 28-days following the discontinuation of HDFA administration.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04723134
Study Brief:
Protocol Section:
NCT04723134