Randomised Clinical Study of Safety and Efficacy of Autologous Bone Marrow Aspirate Concentrate (BMAC) for No-option_critical Limb Ischemia in Type-II Diabetes Mellitus Patients. (DIALEG)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Amputation-free survival
研究概览
简要总结
The aim of the presented clinical trial is to evaluate a hypothesis, that BMAC prepared from bone marrow aspirate and injected intramuscularly into ischemic areas of the lower extremity in patients with diabetes mellitus type II., intraarterially into the defect of the limb or with an intravenous application only, has a greater potential to improve the perfusion in the ischemic limbs than standard treatment of NO-CLI. Another aim of the study is to find out differences among three different therapeutic types of BMAC application, to define their effectiveness and safety and to compare the impact of different means of application to the speed of healing of the limb defects and the improvement of perfusion parameters.
详细描述
Secondary hypothesis assumes, that the intravenous application of BMAC in patients with T2DM older than 30 years of age, with a dose of insulin exceeding 0.7 U/kg/day or 50U/day will result in decreasing the insulin dose in the course of 6-month follow-up and in an improvement of the glycHBA1c levels, improvement of the liver and kidney function, decrease of the cholesterol levels and improvement of the immune response parameters, i.e. parameters of lymphocytar blastic transformation, more than in case of patients with intramuscular or intraarterial application of BMAC.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 diabetes mellitus
- •diagnosis of critical limb ischemia
- •non-healing defect on the study limb
- •ABI value < 50 mmHg or ABI< 0.4
- •TBI value < 40 mmHg or TBI < 0.4
- •TcPO2 < 20 mmHg in supine position
- •no other suitable surgical or re-vascularization procedure
- •age > 18 years
- •signed Informed Consent
排除标准
- •non-signing of the Informed Consent
- •anticipated life expectancy < 6 months
- •history of bone-marrow disease
- •renal failure or dialysis dependency
- •known malignant disease
- •health risks excluding the possibility of general anaesthesia or sedation
- •life-threatening ischaemic heart disease
- •vast necrosis of the index limb
- •active infectious disease, or ATB treatment
- •treatment with immunosupressives
- •pregnancy, breastfeeding
结局指标
主要结局
Amputation-free survival
时间窗: 18 months
The data for Primary outcome will be collected throughout the first 18 months of the study. The assessed parameters will include amputation-free survival in order to verify the safety and efficacy of the treatment.
次要结局
- Functional angiogenesis imaging outcome(4 years)
- Quality of life outcome(4 years)
- Clinical outcome classification(4 years)
- Tissue perfusion parameters(4 years)