Status:
COMPLETED
Macrophage Stimulating Factor in the Treatment of Diabetic Wounds
Lead Sponsor:
Peking University Third Hospital
Conditions:
Diabetic Wound
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
With the aging of the population, the incidence of diseases such as diabetes, chronic atherosclerotic occlusion, cerebrovascular disease, and cancer is increasing year by year, and has led to an incre...
Detailed Description
2\. Approximately 40 people will participate in this study at the Wound Treatment Centre of Peking University Third Hospital. 3\. What is included in this study? Study design: prospective, blinded ev...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06608303
Start Date
October 12 2024
End Date
October 1 2025
Last Update
November 17 2025
Active Locations (1)
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1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191