Guidelines for clinical studies with compression devices in patients with venous disorders of the lower limb.

Objectives: The scientific quality of published clinical trials is generally poor in studies where compression devices have been assessed in the management of venous disease. The authors' aim was to establish a set of guidelines which could be used in the design of future clinical trials of compression treatments for venous diseases.

Design: Consensus conference leading to a consensus statement.

Methods: The authors form a expert consensus group known as the International Compression Club (ICC). This group obtained published medical literature in the field of compression treatment in venous disease by searching medical literature databases. The literature was studied by the group which attended a consensus meeting. A draft document was circulated to ICC members and revised until agreement between contributors was reached.

Results: The authors have prepared a set of guidelines which should be given consideration when conducting studies to assess the efficacy of compression in venous disease.

Conclusions: The form of compression therapy including the comparators used in the clinical study must be clearly characterised. In future studies the characteristics of the material provided by the manufacturer should be described including in vivo data on pressure and stiffness of the final compression system. The pressure exerted on the distal lower leg should be stated in mmHg and the method of pressure determination must be quoted.