Search

Healthcare manufacturing companies have developed many new and novel materials for wound care. They claim that the dressing materials will improve the healing progress of the wound or have a therapeutic value and have sought to assess their efficacy and effectiveness in clinical trials. These claims should be clearly supported by the perspectives of those who actually use the devices. Compression therapy, which is regarded as an effective treatment for venous leg ulcers, is far from ideal owing to a number of limitations that it possesses, such as patient discomfort, difficulty experienced in applying correct compression on the limbs, choosing a correct dressing for the wound or finding differences between the performance of various devices. It is necessary to investigate the patient's views and perspectives while randomized controlled clinical trials are conducted. In this review the concept of quality of life (QoL) and the tools used to measure QoL and studies that were conducted with patients suffering from chronic venous leg ulcers and undergoing therapy are considered, along with contributory factors to the healing process. In addition, a questionnaire modified from the original format is recommended as the suitable tool for assessing the QoL of patients suffering from venous leg ulcers while participating in clinical trials.

Clinical trials must be well designed in order to produce statistically and clinically significant results. This article describes the randomisation techniques that can prevent bias, the importance of sample size and the concept of power analysis.

Clinical trials need to be robust if practitioners are to apply their recommendations into practice. This article describes the various research designs used in wound care and the pitfalls that may compromise the reliability and validity of the results.