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临床试验/NCT04709887
NCT04709887Unknown不适用

Appropriate Strategy of Surgical Treatment in Ischemic Diabetic Foot

Peking University People's Hospital1 个研究点 分布在 1 个国家目标入组 332 人开始时间: 2017年1月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hailin Xu

Associate Professor

Peking University People's Hospital

研究点 (1)

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