RANDOMIZED STUDY TO CHECK THE EFFECTIVENESS OF TOPICAL TREATMENT WITH PLATELET- RICH PLASMA IN THE HEALING OF LOWER LIMBS' VENOUS CHRONIC ULCERS - PULCRO

Servicio de Angiología y cirugía vascular. Hospital Universitario La Paz0 个研究点开始时间: 2017年3月31日最近更新: 2017年7月3日

试验速览

暂无简介。

•1. Age> 18 years.
•2. Ambulation without assistance by other people or by orthoses to perform daily activities.
•3. Ulcer below the knee, with venous etiology, which does not present clinical improvement or reduction of the area after 6 weeks of cures in our center.
•4. Pedal / tibial posterior pulse present or heel-arm index (ITB)> 0.8.
•5. Be able to provide informed consent prior to randomization and agree to comply with all procedures included in this protocol, including the follow-up phase.
•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 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•1. Ischemic aetiology's ulcers.
•2. Ulcers of more than 6 weeks of evolution but with tendency to cicatrization (by photographic comparison with the previous week).
•3. Patients of childbearing age with a positive pregnancy test on the day of screening.
•4. Female patients who are breastfeeding
•5. Male and female patients should agree to use highly effective contraceptive methods from the time of signing informed consent and up to at least 7 days after the completion of the study.

发起方

Servicio de Angiología y cirugía vascular. Hospital Universitario La Paz