Treatment of Venous Ulcers with a Hyaluronic Acid Extracellular Matrix and Compression Therapy

Venous Ulcers Treated With a Hyaluronic Acid Extracellular Matrix and Compression Therapy: Interim Analysis of a Randomized Controlled Trial.

Article specifications

This interim analysis was published in 2017 in Journal of Wounds. (IF 2015:0.17) by American specialists. This is an interim analysis of a prospective, parallel, randomized, single-center study involving 16 subjects in an outpatient wound care center setting, and the objective of the study is to evaluate the safety and effectiveness of a hyaluronic acid extracellular matrix. Each subject with a VLU was randomized (1:1) to receive either HA plus compression with a multilayer compression bandage (MLC) or standard care consisting of a nonadherent primary dressing plus a MLC (control).

 

Results

The incidence of wound healing at 12 weeks was 66.6% for the HA group and 14.2% for the control. Results of this interim analysis indicate that continuation of the present study is warranted and provides a more reliable power calculation forecasting that the inclusion of 50 to 60 subjects would be needed to achieve the statistical goal (P < .05) related to the primary endpoint.