Chronic Ulcer Clinical Trial
Official title:
Feasibility and Safety and Evaluation of the Potential Efficacy of Autologous Platelet-rich Plasma in the Treatment of Vascular Venous Ulcers Compared to Moist Wound Care in a Primary Care Setting
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 practicability, security and potential 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 pilot study will be executed, which will consist in a randomized clinical test,
multicentred, in parallel groups and opened. 40 patients suffering of venous vascular ulcers
will be studied, who will be between the age of 40-80 years old, and who will be attached to
five 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" .
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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