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:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-26 @ 1:16 PM
NCT ID:
NCT05319106
Eligibility Criteria:
Inclusion Criteria:
1. Age from 18 to 70, no gender limitation;
2. It met the diagnostic criteria of venous ulcer of lower limbs in Clinical Vascular Surgery (5th edition), and the following conditions were met: the ulcer lasted for more than 1 month; The wound area was between 10cm2 and 40cm2. Wound depth: All wounds were deep tissue ulcers below the epidermis.
3. Participate in the clinical study voluntarily, observe the study procedure, and observe the curative effect cooperatively.
Exclusion Criteria:
1. Pregnant or lactation women; Women who have planned to have children recently (within 6 months);
2. Patients with peripheral artery disease with ankle-brachial index (ABI) \< 0.8;
3. Patients with active clinical systemic infection;
4. Serious skin wound infection is not under control;
5. low immune function and systemic failure; Severe heart, liver, lung, kidney and other important organ lesions (ALT, AST, Cr \& GT; Normal 1.5 times, congestive heart failure ejection fraction \< Normal 30%) and severely impaired hematopoietic function;
6. Abnormal coagulation function or current anticoagulant treatment;
7. Systemic autoimmune diseases in the active stage;
8. With systemic organ or hematological malignancy;
9. PERSONS infected with HIV or addicted to drugs, tobacco and alcohol;
10. Have a clear history of mental illness;
11. Participation in clinical studies of any drug within 1 month prior to treatment (or the 5 half-life of the investigational drug, whichever is longer).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05319106
Study Brief:
Protocol Section:
NCT05319106