Diabetic Foot Ulcer TreatmentPhase 4NCT06197412
Multi-center Clinical Observation and Mechanism Study of Yunnan Baiyao in Different Stages of Diabetic Foot Ulcer
A Phase 4 study testing Yunnan Baiyao in people with Diabetic Foot Ulcer Treatment, run by Peking University Third Hospital at 1 site in China.
Trial summary
Yunnan Baiyao has been treating all kinds of wounds for 120 years, but the evidence of Evidence-based medicine that is truly convincing is insufficient, making its best application method unclear. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Foot Ulcer Treatment
- What is being tested?
- Yunnan Baiyao
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 31 Mar 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- The age of the subjects is 18-80 years old;
- Diagnose diabetes according to WHO standards;
- Diagnosis of Diabetic foot;
- Confirmed as one of the stages of infection progression and granulation growth;
- Voluntarily participate in this study and sign an informed consent form.
Who cannot join
- Severe diseases such as acute myocardial infarction, heart failure, hepatitis, shock, and respiratory failure have not been corrected yet;
- Blood glucose is out of control, Glucose test#Fasting blood sugar\>15mmol /L, Glycated hemoglobin\>12%;
- There is active bleeding inside the wound, and routine basic treatment plans cannot be implemented;
- Serum albumin\<20g/L; Hemoglobin\<60g/L; Platelets\<50 × 109/L;
- Late stage subjects with malignant tumors;
- Active period of autoimmune diseases;
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- Have a history of allergy to Yunnan Baiyao;
- The subject is unable to cooperate or has mental disorders;
- According to the judgment of the researcher, the subject has a clear reason that cannot be removed and affects wound healing, which is not suitable for this study or cannot comply with the requirements of this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University 3rd Hospital
Beijing
Long hang, Dr, 82267789, longzh2000@126.com
About this study
Yunnan Baiyao has been treating all kinds of wounds for 120 years, but the evidence of Evidence-based medicine that is truly convincing is insufficient, making its best application method unclear. This study explored the possible indications and use methods of Yunnan Baiyao in different stages of Diabetic foot, and obtained Evidence-based medicine evidence of clinical efficacy. Obtain the discarded tissues of Diabetic foot patients in the treatment and control groups of Yunnan Baiyao after wound debridement, conduct Transcriptome (BulkRNA seq) analysis and detection on the wound tissues, and analyze the related signal pathways and functional genes with significant differences, to help clarify the possible treatment targets of Yunnan Baiyao.
- Conditions
- Diabetic Foot Ulcer Treatment
- Being tested
- Yunnan Baiyao
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yunnan BaiyaoDrug
On the basis of the optimal clinical treatment scheme, Yunnan Baiyao powder or ointment was used to treat the wound for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| control group 1 | No intervention | The optimal clinical treatment scheme was used to treat the wound of progressive infection period patients for 2 weeks |
| powder group 1 | Experimental | On the basis of the optimal clinical treatment scheme, Yunnan Baiyao powder was used to treat the wound of progressive infection period patients for 2 weeks Receives: Drug: Yunnan Baiyao |
| ointment group 1 | Experimental | On the basis of the optimal clinical treatment scheme, Yunnan Baiyao ointment was used to treat the wound of progressive infection period patients for 2 weeks Receives: Drug: Yunnan Baiyao |
| control group 2 | No intervention | The optimal clinical treatment scheme was used to treat the wound of granulation period patients for 2 weeks |
| powder group 2 | Experimental | On the basis of the optimal clinical treatment scheme, Yunnan Baiyao powder was used to treat the wound of granulation period patients for 2 weeks Receives: Drug: Yunnan Baiyao |
| ointment group 2 | Experimental | On the basis of the optimal clinical treatment scheme, Yunnan Baiyao ointment was used to treat the wound of granulation period patients for 2 weeks Receives: Drug: Yunnan Baiyao |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-week reduction rate of wound area
Difference in wound area before and after treatment
Measured: 2 weeks
Secondary outcomes (8)
2-week cure rate of wound
Proportion of healed wounds to total number of cases
Measured: 2 weeks
Local infection situation
No infection; local infection reduction; Local infection maintained;Local infection aggravated; Disseminated infection
Measured: 2 weeks
Granulation tissue health status
Healthy granulation, inflammatory granulation, infected granulation, edema granulation, aging granulation
Measured: 2 weeks
Pain scoring
visual analogue scale
Measured: 2 weeks
Microcirculation examination
ankle brachial index, ABI
Measured: 2 weeks
Minor amputation rate
distal ankle amputation
Measured: 3 weeks
Major amputation rate
leg and thigh amputations
Measured: 3 weeks
Mortality
the proportion of dead subjects to total subjects
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start1 Dec 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot Ulcer TreatmentStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 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
- NCT06197412
- Sponsor's protocol ID
- Long2023-YunnanBaiyao
- Status last verified
- Jun 2024
- First submitted
- 17 Dec 2023
- Last updated
- 3 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang Y, Zhao J, Huang E, Li Y, Yin X, Zhang J, Lin Y, Zhang H, Zhang C, Tie L, Wang W, Zhang L. Efficacy and Safety of the Traditional Chinese Medicine Yunnan Baiyao in the Treatment of Diabetic Foot Ulcers: a Multicentre, Randomised Clinical Trial. Basic Clin Pharmacol Toxicol. 2026 Jul;139(1):e70253. doi: 10.1111/bcpt.70253.
PubMed 42236253
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Clinical Observation and Mechanism Study of Yunnan Baiyao in Different Stages of Diabetic Foot Ulcer
- ClinicalTrials.gov ID
- NCT06197412
- Acronym / sponsor ID
- Long2023-YunnanBaiyao
- Conditions
- Diabetic Foot Ulcer Treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 9 Jan 2024 (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.
Yunnan Baiyao has been treating all kinds of wounds for 120 years, but the evidence of Evidence-based medicine that is truly convincing is insufficient, making its best application method unclear. This study explored the possible indications and use methods of Yunnan Baiyao in different stages of Diabetic foot, and obtained Evidence-based medicine evidence of clinical efficacy. Obtain the discarded tissues of Diabetic foot patients in the treatment and control groups of Yunnan Baiyao after wound debridement, conduct Transcriptome (BulkRNA seq) analysis and detection on the wound tissues, and analyze the related signal pathways and functional genes with significant differences, to help clarify the possible treatment targets of Yunnan Baiyao.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| control group 1 | No intervention | –The optimal clinical treatment scheme was used to treat the wound of progressive infection period patients for 2 weeks |
| powder group 1 | Experimental | Drug: Yunnan BaiyaoOn the basis of the optimal clinical treatment scheme, Yunnan Baiyao powder was used to treat the wound of progressive infection period patients for 2 weeks |
| ointment group 1 | Experimental | Drug: Yunnan BaiyaoOn the basis of the optimal clinical treatment scheme, Yunnan Baiyao ointment was used to treat the wound of progressive infection period patients for 2 weeks |
| control group 2 | No intervention | –The optimal clinical treatment scheme was used to treat the wound of granulation period patients for 2 weeks |
| powder group 2 | Experimental | Drug: Yunnan BaiyaoOn the basis of the optimal clinical treatment scheme, Yunnan Baiyao powder was used to treat the wound of granulation period patients for 2 weeks |
| ointment group 2 | Experimental | Drug: Yunnan BaiyaoOn the basis of the optimal clinical treatment scheme, Yunnan Baiyao ointment was used to treat the wound of granulation period patients for 2 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The age of the subjects is 18-80 years old;
- Diagnose diabetes according to WHO standards;
- Diagnosis of Diabetic foot;
- Confirmed as one of the stages of infection progression and granulation growth;
- Voluntarily participate in this study and sign an informed consent form.
Key exclusion criteria (9 listed)
- Severe diseases such as acute myocardial infarction, heart failure, hepatitis, shock, and respiratory failure have not been corrected yet;
- Blood glucose is out of control, Glucose test#Fasting blood sugar\>15mmol /L, Glycated hemoglobin\>12%;
- There is active bleeding inside the wound, and routine basic treatment plans cannot be implemented;
- Serum albumin\<20g/L; Hemoglobin\<60g/L; Platelets\<50 × 109/L;
- Late stage subjects with malignant tumors;
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 |
|---|---|---|
| Yunnan BaiyaoOn the basis of the optimal clinical treatment scheme, Yunnan Baiyao powder or ointment was used to treat the wound for 2 weeks | Drug | ointment group 1, ointment group 2, powder group 1, powder group 2 |
Primary outcome
2-week reduction rate of wound area
Time frame: 2 weeks
Difference in wound area before and after treatment
8 secondary outcomes
2-week cure rate of wound
Time frame: 2 weeks
Local infection situation
Time frame: 2 weeks
Granulation tissue health status
Time frame: 2 weeks
Pain scoring
Time frame: 2 weeks
Microcirculation examination
Time frame: 2 weeks
Minor amputation rate
Time frame: 3 weeks
Major amputation rate
Time frame: 3 weeks
Mortality
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Derived from this study: PubMed 42236253Zhang Y, Zhao J, Huang E, Li Y, Yin X, Zhang J, Lin Y, Zhang H, Zhang C, Tie L, Wang W, Zhang L. Efficacy and Safety of the Traditional Chinese Medicine Yunnan Baiyao in the Treatment of Diabetic Foot Ulcers: a Multicentre, Randomised Clinical Trial. Basic Clin Pharmacol Toxicol. 2026 Jul;139(1):e70253. doi: 10.1111/bcpt.70253.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Yunnan Baiyao in people with Diabetic Foot Ulcer Treatment, 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 9 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: status not confirmed, as of the sponsor's last update on 3 Jul 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
2-week reduction rate of wound area (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06197412, which also lists 1 linked publication.
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 3 Jul 2024.