Clinical trial NCT06841237: Randomized Controlled Trial on the Efficacy and Safety of Xiang Lei Ointment in Diabetic-related Ulcer Management
Official title: Randomized Controlled Trial on the Efficacy and Safety of Xiang Lei Ointment in Diabetic-related Ulcer Management
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetic Wound
Wound Infection
Wound Heal
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2025-02-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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 \&gt; 15 mmol/L and glycated haemoglobin \&gt; 12%;
* active bleeding in the wound, which does not allow the implementation of the conventional basic treatment plan;
* serum albumin \&lt; 20 g/L; haemoglobin \&lt; 60 g/L; platelets \&lt; 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.

Primary outcomes:
measure: wound area reduction rate
timeFrame: From enrollment to the end of treatment at 2 weeks
Secondary outcomes:
measure: wound healing rate
timeFrame: From enrollment to the end of treatment at 3 weeks
measure: Granulation tissue status
timeFrame: From enrollment to the end of treatment at 3 weeks
measure: wound infection control
timeFrame: From enrollment to the end of treatment at 3 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University 3rd Hospital
state: Beijing
Study officials:
References: