NCT02213952.

Trial name or title	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
Methods	Phase III, open‐label, parallel‐group, multicentre, randomised study
Participants	Country: Spain Number randomised (patients): 150 Wound aetiology: Vascular venous ulcer Age: 18 years and older Sex: Male and female Inclusion criteria: Between 40 and 100 years of age with an at least 2‐month history of a vascular venous ulcer Exclusion criteria: ABI below 0.8 or above 1.5. Chronic use of immunosuppressants or antiretroviral drugs. Patients with syphilis, Hepatitis B, Hepatitis C and HIV. Active infection or fever at the beginning of the study. Clotting disorders. Chronic infectious diseases. History of cancer. Treatment with radiotherapy or chemotherapy
Interventions	Experimental: Autologous PRP; one heal per week during the two months of treatment Comparator: Current treatment
Outcomes	Primaries outcomes: Reduction of the ulcer at baseline and 5 and 9 weeks after starting the treatment. The area of the wound will be compared between baseline, after a month and two months of treatment, measuring the area in cm2 by image processing of photographs of the ulcer using ImageJ software Secondary outcomes: Reduction in pain, percentage of infected ulcers and wound edge. Quality of live using the CIVIQ
Starting date	17 December 2012
Contact information	Natalia Burgos Alonso. Unidad de investigacion de atencion Primaria de Bizakaia. Spain natalia.burgosalonso@osakidetza.net
Notes	Founding. Spanish Carlos III Health Institute and Department of Health and Consumer Affairs of the Government of the Basque Country This clinical trial is also registered in clinicaltrial.gov (NCT02213952 Title: PRP ULCERAS: Clinical Trial Phase III (PRPULCERAS))