Feasibility, potential efficacy and safety of autologous platelet-rich plasma in the treatment of vascular venous ulcers in Primary Care (phase I and II pilot study) - PRP in vascular ulcers in primary care

Comarca Ezkerraldea-Enkarterri (OSAKIDETZA)0 个研究点开始时间: 2012年7月19日最近更新: 2012年12月17日

适应症

试验速览

暂无简介。

•?Patients resident in Barakaldo, who are seen in treatment rooms at the Zaballa outpatient clinic or one of the following health centres: Zaballa, La Paz, Urban, or San Vicente, in the Ezkerraldea-Enkarterri Health Region of the Basque Health Service - Osakidetza.
•?Men or women of 40 to 80 years of age
•?Patients with stage C6 chronic venous insufficiency according to the CEAP classification
•?Patients with vascular ulcers which have not responded to conventional treatment in 2 to 6 months
•?Patients with normal number of platelet and red corpuscles and normal range of hematocrit.
•?An ulcer of 3-5 cm in diameter
•?An ABI of greater than or equal to 0.8 or less than or equal to 1.5.
•?Independent patients or with sufficient family support
•?Patients have given written informed consent (Appendices 03 and 04)
•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 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 2

•?Chronic treatment with immunosuppressive or retroviral drugs.
•?Coagulopathies.
•?Patients with chronic infectious diseases.
•?Patients in treatment with radiotherapy or chemotherapy.
•?History of malignancy.
•?Patients with more than two active ulcers.
•?Pregnancy.
•?Patients with current infection or febrile syndrome at the beginning of treatment.
•?Patients with AAI (Ankle Arm Index) less than 0.8 and greater than 1.5

发起方

Comarca Ezkerraldea-Enkarterri (OSAKIDETZA)