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RecruitingNCT06062576Updated Jun 25, 2024

Clinical Observation and Mechanism Study of Yunnan Baiyao in Different Stages of Diabetic Foot

A Phase 4 interventional study of Yunnan Baiyao in Diabetic Foot and Therapeutics, sponsored by Peking University Third Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-06-25.

Sponsored by Peking University Third Hospital · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Started Dec 2023; still recruiting 2 years 10 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study 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. 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.

02

Conditions studied

  • Diabetic Foot
  • Therapeutics

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Keywords

  • Diabetic Foot
  • Therapeutics
03

In context

Diabetic Foot

1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.

This study's planned enrollment of 100 is above the median of 60 across 826 interventional studies indexed under Diabetic Foot.

Browse Diabetic Foot studies →

Lead sponsor

Peking University Third Hospital is the lead sponsor of 735 studies on the registry; 262 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. The age of the subjects is 18-80 years old;
  2. Diagnose diabetes according to WHO standards;
  3. Diagnosis of Diabetic foot;
  4. Confirmed as one of the stages of infection progression and granulation growth;
  5. Voluntarily participate in this study and sign an informed consent form.

Exclusion criteria

Exclusion Criteria:

  1. Severe diseases such as acute myocardial infarction, heart failure, hepatitis, shock, and respiratory failure have not been corrected yet;
  2. Blood glucose is out of control, Glucose test#Fasting blood sugar>15mmol /L, Glycated hemoglobin>12%;
  3. There is active bleeding inside the wound, and routine basic treatment plans cannot be implemented;
  4. Serum albumin\<20g/L; Hemoglobin\<60g/L; Platelets\<50 × 109/L;
  5. Late stage subjects with malignant tumors;
  6. Active period of autoimmune diseases;
  7. Have a history of allergy to Yunnan Baiyao;
  8. The subject is unable to cooperate or has mental disorders;
  9. 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.
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • No intervention
    control group 1

    The optimal clinical treatment scheme was used to treat the wound of progressive infection period patients for 2 weeks

  • Experimental
    powder group 1

    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

    Drug: Yunnan Baiyao

  • Experimental
    ointment group 1

    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

    Drug: Yunnan Baiyao

  • No intervention
    control group 2

    The optimal clinical treatment scheme was used to treat the wound of granulation period patients for 2 weeks

  • Experimental
    powder group 2

    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

    Drug: Yunnan Baiyao

  • Experimental
    ointment group 2

    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

    Drug: Yunnan Baiyao

Interventions

  • DrugYunnan Baiyao

    On the basis of the optimal clinical treatment scheme, Yunnan Baiyao powder or ointment was used to treat the wound for 2 weeks

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What researchers measure

Primary outcomes

  1. 2-week reduction rate of wound area

    Difference in wound area before and after treatment

    Time frame: 2 weeks

07

Study locations

1 of 1 sites recruiting
  • Peking University 3rd Hospital
    Beijing, Beijing 100191, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06062576
Lead sponsor
Peking University Third Hospital
Responsible party
Long Zhang (Professor, Peking University Third Hospital) — Principal investigator
First posted
Oct 2, 2023
Start date
Dec 1, 2023
Primary completion
Dec 31, 2024 (estimated)
Completion
Jun 30, 2025 (estimated)
Last update
Jun 25, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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