Management of Venous Leg Ulcers with Two Active Wound Dressings. Protocol of a Randomized Clinical Trial

The complexity of the healing process and a better understanding of its intrinsic components, has meant many manufacturers have turned towards developing active dressings, after having already developed skin substitutes and growth factors, which are still of very limited use at present, due largely to the high costs of such treatments. Recently, a new matrix containing collagen and oxidized regenerated cellulose, has been made available. In vitro, this matrix has demonstrated both its capacities to deactivate metalloproteinases, which are present in large quantities in chronic wounds, particularly leg ulcers with a detrimental effect on wound healing. This matrix has been assessed clinically in chronic wounds, such as diabetic foot lesions and leg ulcers. The Laboratoires URGO have developed a new wound dressing, which, due to its original compound (NOSF, Nano-Oligo-Sacharid-Factor), demonstrates an in vitro activity against metalloproteinases. A phase III clinical investigation conducted in 27 investigating centres was undertaken in France and UK to assess the performance and safety of the URGO vs the matrix in the local management of venous leg ulcers, in association to a compression therapy. This randomised investigation conducted in parallel groups, is based on a non-inferiority hypothesis between the two tested products, has included 118 patients, followed for a twelve weeks period. The author will present the methodology of this clinical trial : primary and secondary objectives as well as judgement criteria will be discussed. Only such clinical studies will allow wound care professionals to select the more adapted product to manage wounds seen in their daily practice.