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 @ 7:51 PM
Ignite Modification Date:
2025-12-24 @ 7:51 PM
NCT ID:
NCT05577104
Eligibility Criteria:
Inclusion Criteria:
1. Patients with DFUs aged 20-80 years.
2. Wagner grade 2 to 3.
3. Chronic DFUs wounds (duration of disease ≥ 2 weeks).
4. Ankle brachial ratio (ABI) 0.5～0.9, wound area 8\~20 cm2.
Exclusion Criteria:
1. Patients who were unable to complete the follow-up were not included,
2. Pregnant or nursing mothers were not included.
3. Patients with foot ulcers other than diabetes, peripheral vascular disease, organ dysfunctions (heart failure, respiratory failure, liver dysfunction, renal impairment or intestinal failure), or autoimmune diseases (rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, Sjogren's syndrome, connective tissues disease or systemic vasculitis) were not included.
4. Patients who received growth factors or hyperbaric oxygen therapies for the DFUs wounds within one month were not included.
5. Patients who had medications (such as corticosteroids, immunosuppressive agents or chemotherapy) within six months were not included.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
80 Years
Study:
NCT05577104
Study Brief:
Protocol Section:
NCT05577104