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

RecruitingNAAges 18 Years - 80 YearsAllPeking University Third Hospital
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In plain words

What the trial is, and whether it could suit you

Diabetes is one of the major chronic diseases. Diabetic ulcers are important adverse outcomes of diabetes. Approximately 80% of lower - limb amputations are caused by diabetic foot ulcers, which are the main causes of disability and death among patients. Moreover, it places a huge burden on the medical insurance system. Currently, there are western medicine treatment guidelines for diabetic foot, yet the clinical efficacy is less than satisfactory. The amputation rate caused by diabetic foot ulcers continues to rise every year. There is an urgent clinical need for novel and effective intervention measures to address this disease. Macrophages are important cells involved in the inflammatory and proliferative phases of wounds, playing a crucial role in wound repair and reconstruction. Diabetes can cause wounds to remain in the pro - inflammatory stage continuously, leading to the aggregat

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๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Xiang Lei Ointment plus Clinical standard treatment protocols
  • Clinical standard treatment protocols
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Where

1 site
Peking University 3rd Hospital
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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