International angiology : a journal of the International Union of Angiology
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Review
Understanding lower leg volume measurements used in clinical studies focused on venous leg edema.
The aim of this review was to discuss the different techniques of leg edema measurement that have been used in clinical trials to help determine the most appropriate method of assessment and quantification for use in future research. Venoactive drugs such as micronized purified flavonoid fraction (MPFF) are established agents for the treatment of venous leg edema, but results from randomized-controlled trials vary depending on the method of edema assessment. The medical literature was searched for published articles using the terms "venous lower limb edema" and "method of edema assessment." Clinical trials performed with MPFF used leg circumference and optometry for leg edema assessment. ⋯ Patient heterogeneity and method of edema assessment impact clinical trial results. In particular, there are a number of error sources with several methods of assessment that can lead to variability in trial results. Consequently, pilot studies are required to validate new methods of edema assessment using innovative technologies.