Actively Recruiting
Randomized Controlled Trial on the Efficacy and Safety of Xiang Lei Ointment in Diabetic-related Ulcer Management
Led by Peking University Third Hospital · Updated on 2026-03-02
56
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Diabetic foot ulcers are serious complications of diabetes that can lead to disability and amputations, posing a heavy burden on healthcare systems. This clinical trial evaluates Xianglei Tangzu Ointment, a natural medicine approved in 2023, which may help promote healing by influencing immune cells involved in wound repair. Researchers aim to gather clinical evidence on its effectiveness and safety for treating diabetic ulcers, addressing the need for better treatments. Participants will receive either the standard clinical treatment plus Xianglei Tangzu Ointment or the standard treatment alone. The trial is randomized and single-blinded, comparing these two groups over several weeks. The ointment contains plant extracts believed to reduce inflammation and support the wound healing process during the granulation phase. During the study, participants will be monitored for wound healing progress through measurements such as wound area reduction, healing rate, granulation tissue condition, and infection control over two to three weeks. The trial involves regular assessments to track these outcomes and ensure safety throughout the treatment period.
CONDITIONS
Brief Title
Randomized Controlled Trial on the Efficacy and Safety of Xiang Lei Ointment in Diabetic-related Ulcer Management
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of type 1 or type 2 diabetes mellitus with blood glucose controlled and HbA1c less than 10%
- Presence of a diabetic ulcer wound
- Wound caused by diabetic abnormalities leading to poor or prolonged healing
- Wound is in the granulation phase
- Voluntary participation with signed informed consent
You will not qualify if you...
- Serious untreated diseases such as acute heart attack, heart failure, hepatitis, shock, or respiratory failure
- Uncontrolled blood glucose with fasting glucose over 15 mmol/L or HbA1c over 12%
- Active bleeding in the wound preventing standard treatment
- Low serum albumin (less than 20 g/L), hemoglobin (less than 60 g/L), or platelets (less than 50 x 10^9/L)
- Disseminated infection being treated or to be treated with antibiotics
- Advanced malignant tumors
- Active autoimmune disease
- Allergy to topical human granulocyte macrophage stimulating factor gel
- Inability to cooperate or mental disorder
- Investigator judgment of unsuitability or inability to comply with study requirements
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