Evaluation of the Safety and Efficacy of the Treatment of Chronic Wounds in Diabetic Foot Syndrome With the Use of Allogeneic Stem Cells Isolated From Adipose Tissue
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Changes in wound size
研究概览
简要总结
The aim of this study is to investigate efficiency of applying of adipose-derived mesenchymal stem cells (ADSC) in treatment of chronic wounds in diabetic foot syndrome.
详细描述
The product will contain an active ingredient- human allogeneic adipose-derived mesenchymal stem cells (ADSC) cells suspended in the fibrin solution applied directly onto prepared wound bed, to form thin gel layer on the wound surface.
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
- 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
- •Signing informed consent form.
- •Above the age of 18
- •Voluntary participation in the research, following the requirements of the protocol and acceptance for procedures related with its implementation
- •Chronic wound in the course of diabetic foot syndrome, with the wound surface between 1 - 25 sq. cm, without evidence of active infection of the wound at the time of qualification to participate in the study
- •Blood level of glycated haemoglobin (HbA1c) <=11%
- •Satisfactory blood supply to the wound verified by the measurement of the oxygen level in the foot tissue (>=30 mmHg), or by the measurement of systolic blood pressure in posterior or anterior tibial artery (>=50 mmHg) of the affected limb.
- •General health condition, which according to the investigator's opinion, allows patient's participation in all study procedures.
排除标准
- •Lack of patient's cooperation
- •Wound etiology other than diabetic foot syndrome
- •Clinicaly significant limb ischemia as verified by the measurement of the oxygen level in the foot tissue (<30 mmHg), or by the measurement of systolic blood pressure in posterior or anterior tibial artery (<50 mmHg)
- •Active wound infection, which would require the treatment with antibiotics
- •Known allergy to ingredients of study product (thrombin, penicillin).
- •Active venous thromboembolism
- •Any systemic disease (acute or chronic) in the stage of exacerbation or not stabilized, that in the opinion of the investigator may hinder or make impossible a patient's participation in the study
- •Active cancer during chemotherapy or radiotherapy, or recent cancer, if the remission occured less than 5 years before joining the study
结局指标
主要结局
Changes in wound size
时间窗: 8 weeks
The comparison of the time required for the 50% reduction of initial wound size between patients in both study arms. The wound size changes will be assessed using digital 3D wound imaging medical device with image processing software, according to the following rules: * for wounds deeper than 0.5 cm - measurement of wound volume, or * for shallow wounds (less than 0.5 cm depth) - measurement of wound surface.
次要结局
- Changes in pro-angiogenic factors expression(8 weeks)
- Changes in the quality of life(8 weeks)
- Record of adverse events(8 weeks)
- Changes in wound morphology(8 weeks)
- Changes in wound-associated pain(8 weeks)