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

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.

Study Overview

• Status: Recruiting
• Conditions: Wound Infection; Wound Heal; Diabetic Wound
• Intervention / Treatment: Other: Xiang Lei Ointment plus Clinical standard treatment protocols; Other: Clinical standard treatment protocols

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100191
      • Recruiting
      • Peking University 3rd Hospital
      • Contact: Zhang Long, MD; Phone Number: 010 82266699; Email: longzh2000@126.com
      • Principal Investigator: Zhang Long, MD
      • Sub-Investigator: Li Yunfeng, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: test group; Clinical standard treatment protocols plus Xiang Lei Ointment	Other: Xiang Lei Ointment plus Clinical standard treatment protocols; A therapy for chronic wound healing
Sham Comparator: control group; Clinical standard treatment protocols	Other: Clinical standard treatment protocols; A therapy for chronic wound healing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
wound area reduction rate	Pre-treatment area minus post-treatment area, then divided by pre-treatment area	From enrollment to the end of treatment at 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
wound healing rate	Percentage of healed wounds to total cases by D21	From enrollment to the end of treatment at 3 weeks
Granulation tissue status	They were classified as healthy granulation, inflammatory granulation, infected granulation, oedematous granulation, and aged granulation. D0/D14/D21, wound granulation tissue status was recorded separately	From enrollment to the end of treatment at 3 weeks
wound infection control	0 points for no infection, 1 point for reduction of localised infection; 2 points for maintenance or exacerbation of localised infection; 3 points for disseminated infection; record D0/D14/D21, the status of the wound infection and record the scoring results respectively	From enrollment to the end of treatment at 3 weeks

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2025
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): February 15, 2027

Study Registration Dates

• First Submitted: February 18, 2025
• First Submitted That Met QC Criteria: February 18, 2025
• First Posted (Actual): February 24, 2025

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Wound Infection
• Other Study ID Numbers: Long2025-DRW-xianglei

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No