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 @ 7:12 PM
Ignite Modification Date:
2025-12-24 @ 7:12 PM
NCT ID:
NCT06621303
Eligibility Criteria:
Inclusion Criteria:
* (1) Meet the diagnostic criteria for diabetes; (2) Present with clinical symptoms of lower limb ischemia; (3) Ancillary tests suggest lower extremity vascular disease. ABI \<0.9 at rest, or ABI \>0.9 at rest but symptoms of lower limb discomfort occur during exercise, with a decrease in ABI of 15%-20% after a treadmill test or imaging indicates vascular stenosis. If ABI cannot be measured, TBI can be used as a supplementary test, with TBI \<0.7 indicating lower extremity vascular disease.
(4) Male or female adult patients 18 years of age or older (including 18 years). Women of childbearing potential are allowed to be enrolled on the condition that:
* The pregnancy test is negative at the screening visit
* They agree to use appropriate contraceptive measures routinely before and during the study
* They agree not to attempt to become pregnant and not to breastfeed during the study. Women without childbearing potential are defined as postmenopausal for at least one year or surgically sterilized.
(5) Diabetic patients with ulcers, where the ulcer surface area is between 2cm×2cm and 4cm×4cm.
(6) Diabetic foot with Wagner grade II or below, including grade II. (7) Patients with ulcers that have not healed for more than one month. (8) Patients who voluntarily accept cell therapy. (9) After the nature of the study and data disclosure have been explained to the patient, the patient voluntarily signs a written informed consent form and agrees to participate in the study.
Patients with diabetic foot ulcers selected based on the inclusion criteria are classified as having mild ulcers.
Exclusion Criteria:
* (1) Ulcer surface area is less than 2cm×2cm or larger than 4cm×4cm; (2) Diabetic foot with Wagner grade higher than 3, including grade 3; (3) Ulcer onset within 1 month; (4) Patients requiring amputation; (5) Patients with diabetic foot complicated by severe infection; (6) Patients who are HIV positive, syphilis positive, or have active hepatitis B or C virus; (7) Patients with a history of alcohol abuse and/or drug use; (8) Pregnant or lactating mother patients; (9) Patients with malignant tumors or a history of malignant tumors; (10) Patients who are simultaneously participating in or planning to participate in any other clinical studies; (11) Patients with psychiatric or emotional issues; (12) Patients unwilling or unable to provide informed consent; (13) Patients with their own blood system diseases; (14) Patients who have previously had a diabetic foot amputation and have developed a new ulcer.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06621303
Study Brief:
Protocol Section:
NCT06621303