Appropriate Strategy of Surgical Treatment in Ischemic Diabetic Foot
试验速览
- 阶段
- 不适用
- 入组人数
- 332
- 试验地点
- 1
- 主要终点
- Healing rate of wound surface
研究概览
简要总结
This cohort study aims to evaluate the outcomes of appropriate surgical treatment strategies in diabetic foot ulcers with different rate of popliteal artery stenosis(<50% or ≥50%). In this study, patients with Texas university grade 2-4(stage C-D) ischemic diabetic foot ulcers will be included. Data of patients who underwent surgical treatment in the past will be retrospectively collected. The patients with follow-up time less than 12 months will continue to follow up. Also the postoperative patients will be prospectively collected. Effects of different surgical strategies, including wound healing therapy, interventional therapy and tibial transverse bone transport therapy will be measured by several indexes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with diabetic foot, according to "Chinese Guidelines for Diagnosis and Treatment of Diabetic Foot (2017)".
- •Texas university grade 2-4(stage C-D) ischemic diabetic foot ulcers.
- •Have clear consciousness, not suffer from mental illness, can cooperate in research and treatment.
- •Patients who are informed, participate in the research voluntarily, and have signed the informed consent.
- •Have complete clinical data.
排除标准
- •Patients with severe systemic infection, who need to be amputated immediately to save lives.
- •Patients with mental illness, who cannot cooperate to complete the adjustment and nursing of the external fixator.
- •Patients with severe cardiovascular and cerebrovascular diseases (such as severe cardiac insufficiency, severe sequelae of cerebrovascular disease), or with acute infectious diseases.
- •Have used or using glucocorticoids systemically within 3 months before admission.
- •Have participated in other medical clinical trials within 3 months before admission.
- •Patients with severe liver or kidney function abnormalities
- •Pregnant or lactating women.
- •Patients who lost follow-up.
结局指标
主要结局
Healing rate of wound surface
时间窗: 12 months after surgical operation
次要结局
- Ankle-brachial index(12 months after surgical operation)
- Recurrence rate of foot ulcer(12 months after surgical operation)
研究者
Hailin Xu
Associate Professor
Peking University People's Hospital