title: Efficacy and safety of autologous platelet rich plasma for the treatment of vascular ulcers in primary care: Phase III study.
abstract: BACKGROUND
  Vascular ulcers are commonly seen in daily practice at all levels of care and have great impact at personal, professional and social levels with a high cost in terms of human and material resources. Given that the application of autologous platelet rich plasma has been shown to decrease healing times in various different studies in the hospital setting, we considered that it would be interesting to assess the efficacy and feasibility of this treatment in primary care. The objectives of this study are to assess the potential efficacy and safety of autologous platelet rich plasma for the treatment of venous ulcers compared to the conventional treatment (moist wound care) in primary care patients with chronic venous insufficiency (C, clinical class, E, aetiology, A, anatomy and P, pathophysiology classification C6).
  
  
  METHODS
  We will conduct a phase III, open-label, parallel-group, multicentre, randomized study. The subjects will be 150 patients aged between 40 and 100 years of age with an at least 2-month history of a vascular venous ulcer assigned to ten primary care centres. For the treatment with autologous platelet rich plasma, all the following tasks will be performed in the primary care setting: blood collection, centrifugation, separation of platelet rich plasma, activation of coagulation adding calcium chloride and application of the PRP topically after gelification. The control group will receive standard moist wound care. The outcome variables to be measured at baseline, and at weeks 5 and 9 later include: reduction in the ulcer area, Chronic Venous Insufficiency Quality of Life Questionnaire score, and percentage of patients who require wound care only once a week.
  
  
  CONCLUSIONS
  The results of this study will be useful to improve the protocol for using platelet rich plasma in chronic vascular ulcers and to favour wider use of this treatment in primary care.
  
  
  BACKGROUND
  Current Controlled Trials NCT02213952.
authors.affiliation: Ezkerraldea-Enkarterri Health Region, Basque Health Service (Osakidetza), Portugalete, Spain. kepamirena.sansebastianmoreno@osakidetza.net.
authors.forename: Kepa M
authors.initials: KM
authors.lastname: San Sebastian
authors.affiliation: Ezkerraldea-Enkarterri Health Region, Basque Health Service (Osakidetza), Portugalete, Spain. igonelobatogarcia@osakidetza.net.
authors.forename: Igone
authors.initials: I
authors.lastname: Lobato
authors.affiliation: Ezkerraldea-Enkarterri Health Region, Basque Health Service (Osakidetza), Portugalete, Spain. igonehernandezcabezas@osakidetza.net.
authors.forename: Igone
authors.initials: I
authors.lastname: Hernández
authors.affiliation: Primary Care Research Unit of Bizkaia, BioCruces Health Research Institute, Osakidetza, Luis Power 18, planta 4; E-48014, Bilbao, Spain. natalia.burgosalonso@osakidetza.net.|Preventive Medicine and Public Health Department, University of the Basque Country, Faculty of Medicine and Odontology, UPV/EHU, Bilbao, Spain. natalia.burgosalonso@osakidetza.net.
authors.forename: Natalia
authors.initials: N
authors.lastname: Burgos-Alonso
authors.affiliation: Primary Care Research Unit of Bizkaia, BioCruces Health Research Institute, Osakidetza, Luis Power 18, planta 4; E-48014, Bilbao, Spain. Mariacruz.gomezfernandez@osakidetza.net.
authors.forename: Maria Cruz
authors.initials: MC
authors.lastname: Gomez-Fernandez
authors.affiliation: Family Medicine Teaching Unit, Bilbao, Spain. Joseluis.lopezrivas@osakidetza.net.
authors.forename: Jose Luis
authors.initials: JL
authors.lastname: López
authors.affiliation: Bilbao Health Region, Basque Health Service (Osakidetza), Bilbao, Spain. MARIABEGONA.RODRIGUEZRODRIGUEZ@osakidetza.net.
authors.forename: Begoña
authors.initials: B
authors.lastname: Rodríguez
authors.affiliation: Primary Care Research Unit of Bizkaia, BioCruces Health Research Institute, Osakidetza, Luis Power 18, planta 4; E-48014, Bilbao, Spain. anna.ginemarch@osakidetza.net.
authors.forename: Anna Giné
authors.initials: AG
authors.lastname: March
authors.affiliation: Primary Care Research Unit of Bizkaia, BioCruces Health Research Institute, Osakidetza, Luis Power 18, planta 4; E-48014, Bilbao, Spain. Gonzalo.grandesodriozola@osakidetza.net.
authors.forename: Gonzalo
authors.initials: G
authors.lastname: Grandes
authors.affiliation: Regenerative Medicine Laboratory, BioCruces Health Research Institute, Cruces University Hospital, Bilbao, Spain. Isabel.andiaortiz@osakidetza.net.
authors.forename: Isabel
authors.initials: I
authors.lastname: Andia
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D053657:Platelet-Rich Plasma; D011320:Primary Health Care; D011788:Quality of Life; D012883:Skin Ulcer / Q000628:therapy; D016896:Treatment Outcome; D014647:Varicose Ulcer / Q000628:therapy*; D014945:Wound Healing