EUCTR2015-002836-42-ES进行中（未招募）1 期
Phase II Pilot Study to assess security, potential feasibility and effectiveness of treatment with platelet rich plasma in vascular ulcers iwth difficult healing in lower extremities. - Effectiveness and securyty with platelet rich plasma in ulcers.
Asociación Instituto de Investigación Sanitaria BioCruces0 个研究点开始时间: 2017年2月23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
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
- •- Patients who have been treated in the coverage area of the OSI EEC.
- •- Age = 18 years.
- •- Ulcer below the knee of more than 6 weeks of evolution has received conventional treatment.
- •- ABI = 0.7 or otherwise positive distal pulses. Subjects were considered to pulses present those people they feel is achieved, at least, pedal pulses or posterior tibial.
- •- Signature of informed consent.
- •- Ability to be transferred to the HUC (Home Care Service).
- •- Women of childbearing potential must have a negative test result pregnancy and accept the use of contraceptive methods while remaining in the study.
- •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 3
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •- Greater contralateral limb amputation.
- •- Pregnant or lactating women.
- •- Clinical infection of the ulcer.
- •- Blood disorders (thrombopathy, thrombocytopenia, anemia with Hb <9 gr/dl).
- •- Being undergoing systemic immunosuppressive treatments.
- •- Severe heart disease diagnosed.
- •- Patients with active cancer or diagnosed in the last 5 years cancer.
- •- Serological diagnosis of Hepatitis B, C or HIV infection.
- •- Patients who are taking a drug undergoing clinical research or have participated in a study phase clinical research (with a authorized or not) product.
- •- Any physical, social or psychological problem that, in the opinion of the researchers, may affect the patient's participation in the trial or to the validity of the data obtained by participating in it.
- •- Patients unable to comply with scheduled visits.
研究者
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