EUCTR2014-001514-26-ES进行中（未招募）1 期
Efficacy of Autologous Platelet-Rich Plasma in the treatment of vascular ulcers in Primary Care: Clinical trial phase III. - PRP in vascular ulcers in Primary Care
Comarca Ezkerraldea-Enkarterri (OSAKIDETZA)0 个研究点目标入组 150 人开始时间: 2014年6月9日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
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 attending treatment room health centers this s localities,
- •belonging to the Sanitary District of Ezkerraldea-Enkarterri Osakidetza-Basque Health Service.
- •Men and women older than 40 and younger than 100 years old.
- •Patients with chronic venous insufficiency stage C-6 of the CEAP classification.
- •Patients with vascular ulcers unresponsive to conventional treatment for a longer than 2
- •months period.
- •Patients who present an analytical with a normal platelet count and number of serological tests, Hepatitis B: HBsAg, Hepatitis Syphilis negative red blood cells and hematocrit in normal range, and C: Anti-HCV testing genomic amplification and nucleic acid (NTA), HIV I / II: Anti-HIV I / II.
- •One or two together ulcers whose area is equal to or less than 20 cm².
- •Ankle Arm index greater than 0.8 and less than 1.5.
- •self-sufficient family support or to scroll to the health center patients.
- •written informed consent from the patient
- •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 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 75
排除标准
- •Patients on chronic immunosuppressive or retrovirals.
- •Coagulopathies.
- •Patients with chronic infectious diseases: Syphilis, Hepatitis B, Hepatitis C, HIV.
- •Patients treated with radiotherapy or chemotherapy.
- •Patients with history of neoplasia.
- •Patients with more than two active ulcers.
- •Women are breastfeeding or of childbearing age who do not wish to use effective contraception
- •during the clinical trial.
- •Patients with active infection or febrile syndrome at baseline.
- •Patients with ABI less than 0.8 or greater than 1.5.
- •People who are taking a drug undergoing clinical investigation or have been involved in some
- •phasing plug clinical research study in the previous 30 days.
研究者
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