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Clinical Efficacy Observation and Mechanism Study of Yunnan Baiyao in Different Stages of Diabetic Foot
Led by Peking University Third Hospital · Updated on 2024-06-25
100
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of Yunnan Baiyao, a traditional medicine with a long history of wound treatment, in patients with different stages of diabetic foot. This study aims to provide evidence-based data on the clinical effectiveness of Yunnan Baiyao and to explore its possible mechanisms by analyzing wound tissues using advanced gene analysis techniques. The goal is to clarify the potential treatment targets of Yunnan Baiyao in diabetic foot wounds. The study divides participants into groups based on the stage of their diabetic foot wounds—progressive infection or granulation growth. Each group receives either the optimal clinical treatment alone or combined with Yunnan Baiyao powder or ointment applied to the wound for two weeks. This design allows comparison between standard care and Yunnan Baiyao-based treatments over the same duration. Participants will be involved in treatment and wound care for two weeks, during which researchers will monitor wound healing by measuring the reduction rate of the wound area. Tissue samples removed during wound cleaning will undergo gene analysis to identify differences in biological pathways and gene activity. The study monitors participants closely under single-blind conditions and aims to gather comprehensive clinical and molecular data to better understand Yunnan Baiyao's role in diabetic foot treatment.
CONDITIONS
Brief Title
Clinical Observation and Mechanism Study of Yunnan Baiyao in Different Stages of Diabetic Foot
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Diagnosed with diabetes according to WHO standards
- Diagnosed with diabetic foot
- Confirmed to be in either the infection progression or granulation growth stage of the wound
- Willing to participate voluntarily and able to sign informed consent
You will not qualify if you...
- Severe conditions like acute myocardial infarction, heart failure, hepatitis, shock, or respiratory failure not yet corrected
- Poor blood sugar control (fasting blood sugar >15 mmol/L or glycated hemoglobin >12%)
- Active bleeding within the wound preventing routine treatment
- Low serum albumin (<20 g/L), hemoglobin (<60 g/L), or platelets (<50 × 10^9/L)
- Advanced malignant tumors
- Active autoimmune diseases
- Allergy to Yunnan Baiyao
- Unable to cooperate or having mental disorders
- Any other condition judged by the researcher to affect wound healing or study compliance
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants receive treatment with Yunnan Baiyao powder or ointment alongside the optimal clinical treatment scheme for their wound in either the infection progression or granulation growth stage.
Visits as needed over the 2-week treatment period
Trial Site Locations
Total: 1 location
1
Peking University 3rd Hospital
Beijing, Beijing Municipality, China, 100191
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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