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
96 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 aggregation of M1 macrophages and preventing their timely transformation into the pro - proliferative and repair stage. As a result, wounds exhibit persistent chronic inflammation and delayed tissue proliferation or remodeling. Xianglei Tangzu Ointment is a natural medicine approved for marketing by the National Medical Products Administration in November 2023. Its ingredients include Pogostemon cablin extract and asiaticoside. Research shows that the plant components in Xianglei Tangzu Ointment can promote the transformation of M1 macrophages into M2 macrophages, thereby reducing the inflammatory response and accelerating the proliferative repair of diabetic wounds. It has achieved certain curative effects in the clinical treatment of promoting wound healing. In order to use Xianglei Tangzu Ointment more precisely, accumulate clinical evidence - based medicine evidence, and explore the effectiveness and safety of Xianglei Tangzu Ointment in treating diabetic ulcers under the guidance of the chronic wound staging theory, clinical evidence - based medicine evidence needs to be obtained.
CONDITIONS
Official 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 below 10%
- Having a diabetic ulcer wound
- Wound caused by diabetes leading to poor or delayed healing and requiring standard wound therapy
- Wound is in the granulation phase of healing
- Voluntary participation and signed informed consent form
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 blood glucose over 15 mmol/L or HbA1c over 12%
- Active bleeding in the wound preventing standard treatment
- Low serum albumin under 20 g/L, hemoglobin under 60 g/L, or platelets under 50 x 10^9/L
- Disseminated infection currently or planned to be treated with antibiotics
- Advanced malignant tumors
- Active autoimmune disease
- Allergy to topical human granulocyte macrophage stimulating factor gel (Jinfuning)
- Inability to cooperate or mental disorder
- Investigator judgment of unsuitable wound cause or inability to comply with study requirements
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking University 3rd Hospital
Beijing, Beijing Municipality, China, 100191
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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