EUCTR2005-003409-98-BE进行中（未招募）不适用
Enhancement by tacrolimus of nerve regeneration after peripheral nerve repair. - TPNR
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
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
- 性别
- All
入选标准
- •1. Male or female patients of any race, 18 years of age or older.
- •2. Patient presents total nerve section of major nerve of the arm, forearm or leg and undegoing microsurgical suture or graft by hand specialist, within 10 days of trauma (or within 4 months in case of nerve autograft).
- •3. No evidence of wound infection.
- •4. Patient is capable of understanding the purpose and risks of the study, has been fully informed and has given written informed consent to participate in the study.
- •5. Female patients in active sexual years, with contraception.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patient has psychological or general neurological problems.
- •2. Patient has a major skin defect.
- •3. Patient has an avulsive mechanism of nerve injury.
- •4. Patient has a nerve defect obliging to suture under tension.
- •5. Patient has a polytraumatism.
- •6. Patient has a concomitant peripheral nerve affection.
- •7. Patient suffers from arterial hypertension.
- •8. Patient suffers from abnormal renal function (serum creatinin > 1.5 mg/dl).
- •9. Patient suffers from hyperlipidemia.
- •10. Patient suffers from diabetes mellitus.
- •11. Patient is under treatment of glucose-lowering drugs.
- •12. Patient needs concomitant immunosuppressive or steroid treatment.
- •13. Patient is pregnant.
研究者
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