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 @ 7:39 PM
Ignite Modification Date:
2025-12-24 @ 7:39 PM
NCT ID:
NCT06608303
Eligibility Criteria:
Inclusion Criteria:
* a confirmed diagnosis of type 1 or type 2 diabetes mellitus that meets the standard World Health Organization definition, with blood glucose controlled prior to enrolment and a glycated haemoglobin HbA1c level of less than 10%;
* the type of wound is an ulcer;
* the wound etiology is diabetic, mainly abnormalities in blood glucose, resulting in poor or prolonged healing and requiring standard wound therapy;
* the staging of the wound is in the granulation phase;
* voluntary participation in the study and signing of an informed consent form.
Exclusion Criteria:
* acute heart attack, heart failure, hepatitis, shock, expiratory failure and other serious diseases that have not been corrected;
* uncontrolled blood glucose, fasting blood glucose \> 15 mmol/L and glycated haemoglobin \> 12%;
* active bleeding in the wound, which does not allow the implementation of the conventional basic treatment plan;
* serum albumin \< 20 g/L; haemoglobin \< 60 g/L; platelets \< 50 x 109/L;
* a state of disseminated infection that is being or will be treated with antibiotics
* patients with advanced malignant tumours;
* active autoimmune disease;
* previous allergy to topical human granulocyte macrophage stimulating factor gel (Jinfuning);
* inability of the patient to co-operate or mental disorder;
* in the judgement of the investigator, the subject has a clearly irremovable cause of wound healing, is unsuitable for the study or is unable to comply with the requirements of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06608303
Study Brief:
Protocol Section:
NCT06608303