Burgos-Alonso N, Lobato I, Hernández I, Sebastian KS, Rodríguez B, March AG, Perez-Salvador A, Arce V, Garcia-Alvarez A, Gomez-Fernandez MC, Grandes G, Andia I, et al.
Journal of wound care. Date of publication 2018 Jun 1;volume 27(Sup6):S20-S24.
1. J Wound Care. 2018 Jun 1;27(Sup6):S20-S24. doi: 10.12968/jowc.2018.27.Sup6.S20.
Autologous platelet-rich plasma in the treatment of venous leg ulcers in primary
care: a randomised controlled, pilot study.
Burgos-Alonso N(1), Lobato I(2), Hernández I(2), Sebastian KS(3), Rodríguez B(4),
March AG(5), Perez-Salvador A(2), Arce V(5), Garcia-Alvarez A(6), Gomez-Fernandez
MC(7), Grandes G(7), Andia I(8).
Author information:
(1)Primary Care Research Unit of Bizkaia, BioCruces Health Research Institute,
Bilbao, Spain, Preventive Medicine and Public Health Department, University of
the Basque Country. Faculty of Medicine and Odontology. UPV/EHU.
(2)Nurse, Enkarterrri-Ezkerraldea-Cruces Health Region, Basque Health Service
(Osakidetza), Spain.
(3)Enkarterrri-Ezkerraldea-Cruces Health Region, Basque Health Service
(Osakidetza), Spain.
(4)Nurse, Bilbao-Basurto Health Region, Basque Health Service (Osakidetza),
Spain.
(5)Nurse, Primary Care Research Unit of Bizkaia, BioCruces Health Research
Institute, Bilbao, Spain.
(6)Statistician, Primary Care Research Unit of Bizkaia, BioCruces Health Research
Institute, Bilbao, Spain.
(7)Primary Care Research Unit of Bizkaia, BioCruces Health Research Institute,
Bilbao, Spain.
(8)Regenerative Medicine Laboratory, BioCruces Health Research Institute, Cruces
University Hospital, Spain.
OBJECTIVE: To examine the potential efficacy and safety of autologous
platelet-rich plasma (PRP) in comparison with the conventional treatment
(standard care, SoC) for the treatment of leg ulcers in patients with chronic
venous insufficiency, in a primary health-care setting.
METHOD: A Phase I-II, open-label, parallel-group, multicentre, randomised pilot
study was conducted. The outcome variables at baseline and at weeks five and nine
included reduction in the ulcer area, Chronic Venous Insufficiency Quality of
Life Questionnaire score, cost of the treatment for up to nine weeks and average
weekly cure rate.
RESULTS: A total of eight patients, each with at least a six-month history of
venous leg ulcer (VLUs), were included in the study. A total of 12 ulcers were
treated with either autologous PRP or standard SoC. Patients treated with PRP
required wound care only once per week. In the SoC group, patients required
intervention 2-3 times per week. A reduction in the mean ulcer size in the PRP
group was 3.9cm2 compared with the SoC group at 3.2cm 2 , although the sample
size was insufficient to reach statistical significance. Improvement in quality
of life (QoL) score was observed in the patients in the PRP group.
CONCLUSION: This study offers proof-of-concept of the feasibility and safety of
PRP treatment to inform larger clinical trials in patients with VLUs. Our
preliminary results suggest that PRP delivers a safe and effective treatment for
VLU care that can be implemented in primary health-care settings.
DOI: 10.12968/jowc.2018.27.Sup6.S20
PMID: 29883294