Effectiveness of autologous platelet-rich plasma gel in the treatment of hard-to-heal leg ulcers: a randomised control trial.

Abstract

Regenerative medicine products such as autologous platelet-rich plasma (autologous PRP) gel may speed up the process of healing. Clinical studies show promising results in the treatment of diabetic foot ulcers (DFUs), however there is lack of scientific evidence of autologous PRP effectiveness in treating leg ulcers of other aetiology. This study evaluates the effectiveness of autologous PRP gel in the treatment of hard-to-heal leg ulcers compared with existing conventional treatment. A prospective, randomised controlled, open-labelled clinical trial was carried out between 2014 and 2018. An eight-week study protocol was chosen or until 100% wound re-epithelialisation was observed. Wound size reduction, granulation tissue formation, microbiological wound bed changes and safety were evaluated. A total of 69 patients (35 in the autologous PRP group and 34 in the control group) were included in the study; 25.71% of the autologous PRP group and 17.64% of control group had ulcers completely re-epithelialised (p>0.05). Wound size reduction in the autologous PRP group was 52.35% and 33.36% in the control group (p=0.003). The autologous PRP group showed superiority over conventional treatment in wound bed coverage with granulation (p=0.001). However, more frequent wound contamination was observed at the end of treatment in the autologous PRP group (p=0.024). No severe adverse events were noted during the study. Both treatment methods were considered equally safe. Topical application of autologous PRP gel in leg ulcers of various aetiology show beneficial results in wound size reduction and induces the granulation tissue formation. However, it is associated with more frequent microbiological wound contamination.