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

Launched by PEKING UNIVERSITY THIRD HOSPITAL · Feb 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a new ointment called Xianglei Tangzu Ointment for treating diabetic ulcers, which are painful wounds that can occur in people with diabetes. These ulcers can lead to serious complications, including amputations, making it crucial to find better treatments. The ointment is made from natural ingredients and has shown promise in helping wounds heal by reducing inflammation and promoting tissue repair.

To participate in the trial, individuals must be between 65 and 74 years old and have a confirmed diagnosis of type 1 or type 2 diabetes. They should have a specific type of wound called a diabetic ulcer that is in the granulation phase, meaning it is healing but still requires treatment. Participants will need to provide their consent to be part of the study. Throughout the trial, participants will receive care and monitoring to evaluate how well the ointment works. Importantly, individuals with serious health issues or infections that could complicate healing are not eligible to join.

Gender

ALL

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.