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The research adopted an inter-professional theme to fully understand the complex nature of the medical device evaluation process by collaborating with clinical, medical device and psychology professionals. Medical devices are designed for chronic wounds such as venous leg ulcers are a complex unit that need to be fully investigated for their safety, efficacy and effectiveness. The main issues examined in this work are: selection of specific areas of enhancing the quality of clinical trials, demonstration of planning and design process of a clinical trial by participating in a NHS based clinical research and finally recommendations for an optimum standard for evaluation of medical devices for this patient group. The various ways in which clinical trials can be conducted along with the strengths and limitations of different types of clinical trials are critically analysed. The contextual factors such as patient compliance with treatment, professional practice of adopting research-based evidence and patients´ perspectives influencing the treatment of venous leg ulcers are critically examined.

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Praburaj D. Venkatraman, PhD: Studied Technology at K.C.T, Coimbatore, India, He completed MSc. in Technical Textiles at Bolton Institute, U.K. He did research on medical devices for wound healing and obtained PhD from University of Bolton, U.K. and currently working at Manchester Metropolitan University, Manchester, U.K. as a Senior Lecturer.

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