Chronic edema of the lower extremities: international consensus recommendations for compression therapy clinical research trials.

INTERNATIONAL ANGIOLOGY August 2012 An international panel of experts convened a day-long conference in Brighton, United Kingdom, in March 2010, to examine the current state of clinical practice and evidence base to support the use of compression modalities in managing chronic edema. This expert panel organized by the International Compression Club (www.icccompressionclub.com) is a recognized entity in providing evidence-based consensus documents, most recently regarding compression therapy for breast cancer related lymphedema.1 The goal of this session was to examine gaps in the current literature, investigate disparities in current clinical practice and make recommendations for future clinical trials that may further optimize practice in compression management of patients with chronic edema. The aim of this document was to present prerequisites for future clinical trials in an effort to close the identified gaps and answer important clinical questions. A secondary purpose of this document was to inform industry of trials needed to examine the effectiveness of materials commonly used to treat chronic edema. Chronic edema is a multifactorial condition affecting patients with various diseases. Although the pathophysiology of edema varies, compression therapy is a basic tenant of treatment, vital to reducing swelling. Clinical trials are disparate or lacking regarding specific protocols and application recommendations for compression materials and methodology to enable optimal efficacy. Compression therapy is a basic treatment modality for chronic leg edema; however, the evidence base for the optimal application, duration and intensity of compression therapy is lacking. The aim of this document was to present the proceedings of a day-long international expert consensus group meeting that examined the current state of the science for the use of compression therapy in chronic edema. An expert consensus group met in Brighton, UK, in March 2010 to examine the current state of the science for compression therapy in chronic edema of the lower extremities. Panel discussions and open space discussions examined the current literature, clinical practice patterns, common materials and emerging technologies for the management of chronic edema. This document outlines a proposed clinical research agenda focusing on compression therapy in chronic edema. Future trials comparing different compression devices, materials, pressures and parameters for application are needed to enhance the evidence base for optimal chronic oedema management. Important outcomes measures and methods of pressure and oedema quantification are outlined. Future trials are encouraged to optimize compression therapy in chronic edema of the lower extremities. [Int Angiol 2012;31:316-29]