Diabetic WoundNCT06841237
Randomized Controlled Trial on the Efficacy and Safety of Xiang Lei Ointment in Diabetic-related Ulcer Management
A study testing Xiang Lei Ointment plus Clinical standard treatment protocols and Clinical standard treatment protocols in people with Diabetic Wound and Wound Infection, run by Peking University Third Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Wound, Wound Infection, Wound Heal
- What is being tested?
- Xiang Lei Ointment plus Clinical standard treatment protocols and Clinical standard treatment protocols
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2025to 15 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University 3rd Hospital
Beijing, Beijing Municipality, 100191
Zhang Long, MD, 82266699 ext. 010, longzh2000@126.com
Zhang Long, MD
About this study
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
- Diabetic Wound, Wound Infection, Wound Heal
- Being tested
- Xiang Lei Ointment plus Clinical standard treatment protocols, Clinical standard treatment protocols
- Medical subject headings
- Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xiang Lei Ointment plus Clinical standard treatment protocolsOther
A therapy for chronic wound healing
Clinical standard treatment protocolsOther
A therapy for chronic wound healing
| Study group | Role | What they receive |
|---|---|---|
| test group | Experimental | Clinical standard treatment protocols plus Xiang Lei Ointment Receives: Other: Xiang Lei Ointment plus Clinical standard treatment protocols |
| control group | Sham comparator | Clinical standard treatment protocols Receives: Other: Clinical standard treatment protocols |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound area reduction rate
Pre-treatment area minus post-treatment area, then divided by pre-treatment area
Measured: From enrollment to the end of treatment at 2 weeks
Secondary outcomes (3)
wound healing rate
Percentage of healed wounds to total cases by D21
Measured: 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
Measured: 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
Measured: From enrollment to the end of treatment at 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start10 Apr 2025
- Primary completion15 Jul 2026 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic WoundStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, Randomized, Open-lable
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Long Zhang, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06841237
- Sponsor's protocol ID
- Long2025-DRW-xianglei
- Status last verified
- Feb 2026
- First submitted
- 18 Feb 2025
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial on the Efficacy and Safety of Xiang Lei Ointment in Diabetic-related Ulcer Management
- ClinicalTrials.gov ID
- NCT06841237
- Acronym / sponsor ID
- Long2025-DRW-xianglei
- Conditions
- Diabetic Wound, Wound Infection, Wound Heal
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 24 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Multicenter, Randomized, Open-lable
| Arm | Type | Receives |
|---|---|---|
| test group | Experimental | Other: Xiang Lei Ointment plus Clinical standard treatment protocolsClinical standard treatment protocols plus Xiang Lei Ointment |
| control group | Sham comparator | Other: Clinical standard treatment protocolsClinical standard treatment protocols |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xiang Lei Ointment plus Clinical standard treatment protocolsA therapy for chronic wound healing | Other | test group |
| Clinical standard treatment protocolsA therapy for chronic wound healing | Other | control group |
Primary outcome
wound area reduction rate
Time frame: From enrollment to the end of treatment at 2 weeks
Pre-treatment area minus post-treatment area, then divided by pre-treatment area
3 secondary outcomes
wound healing rate
Time frame: From enrollment to the end of treatment at 3 weeks
Granulation tissue status
Time frame: From enrollment to the end of treatment at 3 weeks
wound infection control
Time frame: From enrollment to the end of treatment at 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: No
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EDX110 Randomized Control Trial for Treatment of DFUs
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Impact of Screening and Multicomponent Exercise on Fall Rates, Fractures, and Cardiovascular Health in Diabetes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xiang Lei Ointment plus Clinical standard treatment protocols and Clinical standard treatment protocols in people with Diabetic Wound and Wound Infection, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wound area reduction rate (time frame: From enrollment to the end of treatment at 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.