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 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT05046158
Eligibility Criteria:
Inclusion Criteria:
* 18-89 years old
* Diagnosed with diabetes Mellitus; hemoglobin A1C \< 12%
* Diabetic foot ulcer present for minimum 30 days (Wagner grade 1 or 2 classification)
* Wound drainage is minimal or moderate
* No clinically active wound infection
* Able and willing to provide consent
* Has not participated in another research trial within 3 months of enrollment.
Exclusion Criteria:
* Unable to keep weekly research appointments
* Unable or unwilling to use offloading device if recommended
* Wounds with large amount (high) drainage
* Active gangrene
* Wounds impending surgical intervention (including revascularization or plastic surgery)
* Untreated osteomyelitis
* Soft tissue infection (can be enrolled once infection is cleared)
* Active Charcot arthropathy
* BMI \>45kg/m2
* History of AIDS
* History of organ transplant or impending transplant
* End stage renal disease requiring dialysis
* Decompensated hepatic or cardiac disease
* Select autoimmune diseases
* Lymphedema
* Oral steroid use in last 3 months
* Venous stasis disease
* Active malignancy (cancer)
* Unable to sign consent
* Active alcohol or substance abuse
* Pregnant or lactating women
* Insufficient vascular flow to heal a wound
* Hemoglobin A1C \>12%
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
89 Years
Study:
NCT05046158
Study Brief:
Protocol Section:
NCT05046158