Autologous platelet-rich plasma in the treatment of venous leg ulcers in primary care: a randomised controlled, pilot study.

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.

Key aspects related to implementation of risk stratification in health care systems-the ASSEHS study.

BACKGROUND: The lack of proven efficacy of new healthcare interventions represents a problem for health systems globally. It is partly related to suboptimal implementation processes, leading to poor adoption of new interventions. Activation of Stratification Strategies and Results of the interventions on frail patients of Healthcare Services (ASSEHS) EU project (N° 2013 12 04) aims to study current existing health Risk Stratification (RS) strategies and tools on frail elderly patients. This paper aims at identifying variables that make the implementation of population RS tools feasible in different healthcare services. METHODS: Two different methods have been used to identify the key elements in stratification implementation; i) a Scoping Review, in order to search and gather scientific evidence and ii) Semi-structured interviews with six key experts that had been actively involved in the design and/or implementation of RS strategies. It aims to focus the implementation construct on real-life contextual understandings, multi-level perspectives, and cultural influences. RESULTS: A Feasibility Framework has been drawn. Two dimensions impact the feasibility of RS: (i) Planning, deployment and change management and (ii) Care intervention. The former comprises communication, training and mutual learning, multidisciplinarity of the team, clinicians' engagement, operational plan and ICT display and functionalities. The latter includes case finding and selection of the target population, pathway definition and quality improvement process. CONCLUSIONS: The Feasibility Framework provides a list of key elements that should be considered for an effective implementation of population risk stratification interventions. It helps to identify, plan and consider relevant elements to ensure a proper RS implementation.

Efficacy and safety of autologous platelet rich plasma for the treatment of vascular ulcers in primary care: Phase III study.

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). DESIGN: 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. DISCUSSION: 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. TRIAL REGISTRATION: Current Controlled Trials NCT02213952.