Randomized Controlled Trial on the Efficacy and Safety of Xiang Lei Ointment in Diabetic-related Ulcer Management

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.