Actively Recruiting

Phase 4
Age: 18Years - 80Years
All Genders
NCT06197412

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

Led by Peking University Third Hospital · Updated on 2024-07-03

100

Participants Needed

1

Research Sites

121 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 80 years old
  • Diagnosed with diabetes according to WHO standards
  • Diagnosis of diabetic foot
  • Confirmed as one of the stages of infection progression or granulation growth
  • Voluntarily agree to participate and sign informed consent
Not Eligible

You will not qualify if you...

  • Severe uncontrolled diseases such as acute myocardial infarction, heart failure, hepatitis, shock, or respiratory failure
  • Uncontrolled blood glucose: fasting blood sugar >15 mmol/L or glycated hemoglobin >12%
  • Active bleeding inside the wound preventing routine basic treatment
  • Low blood protein or blood cell counts: serum albumin <20 g/L, hemoglobin <60 g/L, or platelets <50 × 10^9/L
  • Late-stage malignant tumors
  • Active autoimmune disease
  • History of allergy to Yunnan Baiyao
  • Unable to cooperate or has mental disorders
  • Any other condition judged by researchers to affect wound healing or study compliance

AI-Screening

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Trial Site Locations

Total: 1 location

1

Peking University 3rd Hospital

Beijing, China

Actively Recruiting

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