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Multi-center Clinical Observation and Mechanism Study of Yunnan Baiyao in Different Stages of Diabetic Foot Ulcer

ConditionDiabetic Foot Ulcer Treatment
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPeking University Third Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Yunnan Baiyao

    Drug

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

Treatment groups

100 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: control group 1No intervention 0 interventions
Group B: powder group 1Experimental treatment 1 intervention
Group C: ointment group 1Experimental treatment 1 intervention
Group D: control group 2No intervention 0 interventions
Group E: powder group 2Experimental treatment 1 intervention
Group F: ointment group 2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

2-week reduction rate of wound area

Difference in wound area before and after treatment

Time frame
2 weeks

Secondary outcomes

1

2-week cure rate of wound

Proportion of healed wounds to total number of cases

Time frame
2 weeks
2

Local infection situation

No infection; local infection reduction; Local infection maintained;Local infection aggravated; Disseminated infection

Time frame
2 weeks
3

Granulation tissue health status

Healthy granulation, inflammatory granulation, infected granulation, edema granulation, aging granulation

Time frame
2 weeks
4

Pain scoring

visual analogue scale

Time frame
2 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University Third Hospital

Lead sponsor

Source ClinicalTrials.gov
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