Clinical Observation and Mechanism Study on the Therapeutic Effect of Electroacupuncture at Zusanli (ST-36) in Promoting Diabetic Foot Wound Healing Through Mediating Macrophage Polarization
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Wagner Grade and Ankle-Brachial Index (ABI) Measurement
研究概览
简要总结
The goal of this clinical trial is to learn if electroacupuncture at the Zusanli (ST-36) can assist in the treatment of diabetic foot ulcers. The main question it aims to answer is: Can electroacupuncture at the Zusanli (ST-36) promote wound healing in patients with diabetic foot ulcers?
Researchers will compare outcomes between participants receiving electroacupuncture plus standard treatment and those receiving standard treatment alone to assess the effect of Zusanli (ST36) stimulation on wound healing in patients with diabetic foot ulcers.
Participants will:
Receive standard diabetes treatment (including diabetes education, dietary control, insulin combined with oral hypoglycemic agents to manage blood glucose, and effective antibiotics to control infection. For patients with foot ulcers, the wound will be cleaned with saline; abscesses will be drained if present; daily dressing changes.) Participants in the electroacupuncture group will receive electroacupuncture at Zusanli(ST-36) every day; 6 sessions constitute one treatment course, for a total of 4 courses.
Visit the hospital for examinations before treatment and after each treatment course to measure the ankle-brachial index (ABI), assess diabetic foot Wagner grade, and evaluate hemodynamic parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria for diabetic foot ulcers;
- •Meet the criteria for Traditional Chinese Medicine syndrome differentiation, classified as blood stasis obstructing the collateral pattern;
- •Wagner Grade 1-3, with ulcer area ranging from 2 cm² to 30 cm²;
- •Male or female, aged between 18 and 75 years;
- •Provide signed informed consent, voluntarily participate in this study, and demonstrate good compliance.
排除标准
- •Complicated with severe diseases of the brain, liver, heart, lungs, or kidneys;
- •Pregnant women or women planning to become pregnant;
- •Glycosylated hemoglobin (HbA1c) level ≥ 9%;
- •Complicated with psychiatric disorders;
- •Complicated with genetic or infectious diseases, malignant tumors, or other severe conditions associated with a short life expectancy;
- •Concurrent participation in other clinical trials or participation within 4 weeks prior to randomization.
结局指标
主要结局
Wagner Grade and Ankle-Brachial Index (ABI) Measurement
时间窗: From enrollment to completion of all 4 treatment courses (each traatment courses is one week)
Wagner grade and ankle-brachial index (ABI) are measured before treatment and after each treatment course. The outcomes are defined as follows: Cure: A decrease of two grades in the Wagner classification, ABI \> 1.0, stable diabetes status, and complete resolution of clinical symptoms. Improvement: A decrease of one grade in the Wagner classification, 0.5 ≤ ABI ≤ 1.0, and significant improvement of clinical symptoms. No improvement: No significant improvement or worsening of the patient's condition after treatment.
次要结局
- Hemodynamic parameters (vascular inner diameter)(From enrollment to completion of all 4 treatment courses (each traatment courses is one week))
- Hemodynamic parameters (blood flow volume)(From enrollment to completion of all 4 treatment courses (each traatment courses is one week))
研究者
Dachun Chen
Attending Physician of Traditional Chinese Medicine
Zongda Hospital affiliated to Southeast University