EUCTR2016-004109-15-PL进行中（未招募）1 期
Evaluation of the safety and efficacy of the treatment of chronic wounds in diabetic foot syndrome with the use of autologous stem cells isolated from adipose tissue - within the project: Therapeutic potential of adipose-derived stem cells, proven in clinical trials and examined in vitro - rationale for banking of well characterized cells”
Medical University of Warsaw0 个研究点目标入组 50 人开始时间: 2017年5月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1.Signing informed consent form.
- •2.Above the age of 18
- •3.Voluntary participation in the research, following the requirements of the protocol and acceptance for procedures related with its implementation
- •4.Chronic wound in the course of diabetic foot syndrome, with duration of at least 12 weeks and the wound surface not less than 2 sq. cm and not greater than 25 sq. cm, without evidence of active infection of the wound at the time of qualification to participate in the study
- •5.Blood glucose control - fasting not more than 180 mg% OR HbA1c not more than 10%.
- •6.Good tolerance of the current standard of treatment lasting at least one week before including the patient into the study
- •7.Satisfactory blood supply to the wound verified by the measurement of the oxygen level of the foot tissue (> 20mmHg) in patients with neuropathic etiology of diabetic foot syndrome
- •8.In the case of the patients with the wounds of ischemic component, the condition for qualification is a clinical improvement of the limb’s blood supply as a result of the revascularization procedure documented by X-ray or ultrasound.
- •9.Ankle-brachial index (ABI) = 0.8
- •10.No active infection of the wound and surrounding tissue verified by quantitative microbiological testing (105 bacteria per 1 g of tissue taken for testing from a wound)
- •11.For women of childbearing potential - a negative pregnancy test result during the screening visit and using of effective contraceptive methods during participation in the research.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •1.Lack of patient’s cooperation
- •2.Ischemia of lower limbs; ankle-brachial index <0.8; significant vein component in medical patient’s history shown in the Duplex-Doppler tests made within 6 months before joining the research.
- •3.Active cancer during chemotherapy or radiotherapy, or recent cancer, if the remission had place less than 5 years before joining the study
- •4.No clinical improvement after revascularization procedures performed on the vascular system of the treated limb during the last 2 weeks
- •5.Venous thromboembolism in the past 3 months preceding participation in the research
- •6.Sings of severe osteolysis and / or bone and marrow infection around wounds on the basis of the result of X-ray, CT or MRI of the feet made within 6 months before participation in the study.
- •7.The active inflammation phase in the course of Charcot's neuroartropathy.
- •8.Treatment with antibiotics, immunosuppressive therapy, including systemic steroid therapy (excluding inhaled medicines) at the time of joining the study.
- •9.Chronic diseases in the stage of exacerbation, not stabilized, that in the opinion of the investigator may hinder or make impossible a patient’s participation in the study and reviewed on the basis of subjective and objective examination and laboratory tests carried out during the screening visit (blood type, morphology, electrolytes, coagulation system, blood glucose, urea, creatinine, and viral tests). Test results behind laboratory standards for a specific parameter are considered as incorrect. In the case of treatment with vitamin K antagonists, normal ranges suitable for this treatment will apply.
- •10.Known allergic reactions to ingredients of dressing (thrombin, penicillin).
- •11.The diagnosis of AIDS, HBV or HCV
- •12.Reactive result of serological and viral tests:
- •HIV-1 and 2 (HIV Ag / Ab);
- •Hepatitis B Virus Infection, Anti-HBc;
- •Hepatitis C Virus Infection, Anti-HCV;
- •Syphilis specific tests
研究者
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