Multicentre Study on Diabetic Foot Treatment by Tibial Transportation Combined With Autologous Mesenchymal Stem Cells Local Infusion
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- visual analogue scale
研究概览
简要总结
With a rapidly growing incidence rate and a high disability rate,The Diabetic Foot has long been difficult to treatment, which has caused a huge burden to patients and society. The blood supply disorder is one of the main reasons that lead to the morbidity and difficulty in healing of diabetes feet, but there is still a lack of particularly effective treatment to improve the blood supply of diabetes feet. Both transverse bone transport and bone marrow cell transplantation have shown some clinical effects. However, the difference in efficacy between the two has not been reported. In this study, investigators compared the therapeutic effects of these two methods on the healing of diabetes foot ulcers through a controlled clinical study.
详细描述
In this study, investigators compared the therapeutic effects of Tibial Transportation Combined With Autologous mesenchymal stem cells Local Infusion on the healing of diabetes foot ulcers through a controlled clinical study.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptoms: Wagner stage 2 or above foot ulcer (deep ulcer, abscess or osteomyelitis; localized gangrene, characterized by ischemic gangrene, usually with neuropathy; gangrene of the whole foot), may be accompanied by chronic limb pain, intermittent claudication, cold sensation, abnormal skin sensation and other symptoms
- •Have not taken reserpine in the past week or can change to other antihypertensive drugs
- •Voluntary participation and signing of informed consent
排除标准
- •Patients with organ failure diagnosed by doctors in the past: such as heart failure, liver and kidney failure
- •Patients with myocardial infarction diagnosed by doctors in the past
- •With congenital or acquired organic heart disease
- •With basic disease is in the active stage, such as newly diagnosed leukemia patients, or leukemia patients with relapse and refractory
- •Active infection: pulmonary infection, intestinal infection and other existing infections
- •Severe anemia
- •Severe osteoporosis
- •Have undergone amputation of both lower limbs
- •The investigator judged that it was not suitable to participate in this study, including the existence of abnormal laboratory test results or clinical abnormal symptoms/signs
- •There are any of the following conditions that may limit the patient's compliance or hinder data collection: dementia; Serious mental disorder, unable to express will; Unable to complete the research evaluation as required
- •Other contraindications of anesthesia or surgery
结局指标
主要结局
visual analogue scale
时间窗: 3 months after surgery
Visual analog scale (VAS) and its corresponding visual analog pain scale, is a psychometric scale that is generally used in hospitals and clinics by doctors to conduct pain scale surveys to understand varying degrees of pain or discomfort experienced by a patient.VAS ranges from 0 to 10 and a higher score means worse outcome.
次要结局
- Ankle brachial index(3 months after surgery)
- Painless walking distance(3 months after surgery)
- ulcer area(3 months after surgery)
- Wagner grade(3 months after surgery)
- skin temperature(day after surgery)