Clinical trial NCT02213952: PRP ULCERAS: Clinical Trial Phase III
Official title: Efficacy of Autologous Platelet-Rich Plasma in the Treatment of Vascular Ulcers in Primary Care: Clinical Trial Phase III
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Ulcer
Keywords: Ulcer
Platelet-Rich Plasma
Lead sponsor: Basque Health Service
Sponsor class: OTHER_GOV
Collaborators: name: Osakidetza
First posted: 2014-08-12
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: INTRODUCTION: Vascular ulcers are an important pathology in the daily medical practice in all the assistance levels, and they have big repercussion referring to individual, social and labour levels, supposing a big consumption of human and material resources.The cure with autologous platelet rich plasma (autologous PRP) has demonstrated in different studies a decrease in the cicatrization time comparing to conventional methods in hospital levels, which becomes interesting contrasting its efficacy in primary care.

AIM:Evaluate the efficacy of the autologous PRP in the treatment of vascular ulcers, comparing to the conventional treatment ( cure with humid environment), in primary care patients with chronic venous insufficiency in C-6 degree (CEAP classification).

DESIGN: A study will be executed, which will consist in a randomized clinical test, multicentered, in parallel groups and opened. 150 patients suffering of venous vascular ulcers will be studied, who will be between the age of 40-100 years old, and who will be attached to 10 health centers. Variables for the identification, following, result and patient profile have been defined. Emphasize the variables of "ulcer area decreasing", "CIVIQ index", "% one cure per week".

Detailed description: Vascular ulcers are an important pathology in the daily medical practice in all the assistance levels, and they have big repercussion referring to individual, social and labour levels, supposing a big consumption of human and material resources.The cure with autologous platelet rich plasma (autologous PRP) has demonstrated in different studies a decrease in the cicatrization time comparing to conventional methods in hospital levels, which becomes interesting contrasting its efficacy in primary care.The aim of this study is to evaluate the efficacy of the autologous PRP in the treatment of vascular ulcers, comparing to the conventional treatment (cure with humid environment), in primary care patients with chronic venous insufficiency in C-6 degree (CEAP classification). It is a study which will consist in a randomized clinical test, multicentered, in parallel groups and opened 150 patients suffering of venous vascular ulcers will be studied. Variables for the identification, following, result and patient profile have been defined. Emphasize the variables of "ulcer area change", "CIVIQ index", "% one cure per week".

Eligibility criteria: Inclusion Criteria:

* Patients from Barakaldo and Bilbao, who come to the treatment room at health centers in these towns belong to the OSI Ezkerraldea-Enkarterri-Cruces of Osakidetza-Basque Health Service.
* Men or women older than 18 years old.
* Patients with chronic venous insufficiency stage C-6 of the CEAP classification.
* Patients with vascular ulcers unresponsive to conventional treatment over a 2 months period or recurrence of previous venous ulcers.
* Patients who present an analytical before entering the studio, platelets and red blood cell count and hematocrit in normal range
* Ulcers whose diameter size is 30cm² or less.
* Greater Ankle Arm Index 0.8 and less than 1.5.
* Patients with recent analytic with number platelet and red blood cell count and hematocrit normal range.
* Patients with recent analytic negative to: Syphilis serology, Hepatitis B: HBsAg, Hepatitis C: Anti-HCV tests genomic nucleic acid amplification (NAT), HIV I / II: Anti-HIV I / II.
* Self or family support sufficient to move patients to the health center.
* Written informed consent of the patient

Exclusion Criteria:

* Patients on chronic immunosuppressive or retroviral.
* Coagulopathy
* Patients with chronic infectious diseases.
* Patients treated with radiotherapy or chemotherapy, or history of neoplasia.
* Patients with more than two active ulcers.
* Pregnant or childbearing potential not want to use contraception.
* Women breastfeeding.
* Patients with active infection or febrile syndrome at baseline.
* People who are taking a drug under clinical investigation or participated in any study under clinical investigation in the previous 30 days.

Primary outcomes:
measure: ULCER SIZE CHANGE
timeFrame: Change from baseline at 9 weeks
Secondary outcomes:
measure: QUALITY OF LIFE (INDEX CIVIQ)
timeFrame: Change from baseline at 9 weeks
measure: Change of the percentage OF PATIENTS WITH A ONLY ONE TREATMENT FOR WEEK
timeFrame: Change from baseline at 9 weeks
Other outcomes:
Locations:
city: Portugalete
country: Spain
facility: Comarca Enkarterri Ezkerraldea
state: Bizakaia
city: Bilbao
country: Spain
facility: UIAPB
state: Bizkaia
Study officials:
affiliation: C. Ezkerraldea Enkarterri.
name: Kepa Mirena San Sebastian Moreno
role: PRINCIPAL_INVESTIGATOR
affiliation: C. Ezkerraldea Enkarterri
name: Igone Hernández Cabezas.
role: STUDY_CHAIR
affiliation: C. Ezkerraldea Enkarterri
name: Igone Lobato García
role: STUDY_CHAIR
affiliation: C. Bilbao
name: Begoña Rodríguez Rodríguez.
role: STUDY_CHAIR
affiliation: C. Ezkerraldea Enkarterri
name: Ariadna Pérez Salvador
role: STUDY_CHAIR
affiliation: Primary Care Research Unit of Bizkaia
name: Gonzalo Grandes Odriozola
role: STUDY_CHAIR
affiliation: Primary Care Research Unit of Bizkaia
name: Natalia Burgos Alonso.
role: STUDY_DIRECTOR
affiliation: Primary Care Research Unit of Bizkaia
name: Anna Giné March
role: STUDY_DIRECTOR
affiliation: C. Ezkerraldea Enkarterri
name: Kepa Mirena San Sebastian Moreno
role: PRINCIPAL_INVESTIGATOR
References:
citation: San Sebastian KM, Lobato I, Hernandez I, Burgos-Alonso N, Gomez-Fernandez MC, Lopez JL, Rodriguez B, March AG, Grandes G, Andia I. Efficacy and safety of autologous platelet rich plasma for the treatment of vascular ulcers in primary care: Phase III study. BMC Fam Pract. 2014 Dec 30;15:211. doi: 10.1186/s12875-014-0211-8.