Efficacy and safety of a gauze pad containing hyaluronic acid in treatment of leg ulcers of venous or mixed origin: a double-blind, randomized, controlled trial
This double-blind, randomized, controlled trial was published in 2013 in International Wound Journal (IF 2014: 2.594) by French, Moroccan and polish dermatologists. The aim of this study is investigating the efficacy and safety of a gauze pad containing HA in local treatment of venous leg ulcers, compared with its neutral vehicle. Totally 89 patients (aged 18 years or over, with one or several leg ulcers of venous or mixed arterial/venous origin present for >2 months and <4 years) were included (38 in HA group and 34 in Neutral vehicle group). A total of five visits were carried out by the same investigator for each patient: an inclusion visit (day 0), three intermediary evaluation visits (day 15 ± 2, day 30 ± 3, day 45 ± 3) and a final evaluation visit (day 60 ± 3). The primary endpoint was the percentage of wound size reduction after 45 days.
For the first time, to the best of our knowledge such a well-conducted clinical study clearly shows that the local application of HA using an impregnated gauze pad on venous leg ulcers is significantly more effective than neutral vehicle gauze pad regarding a widely accepted quantitative endpoint (i.e. reduction of wound size at D45) and effective wound closure rate with a good safety profile. In this study, pain-related secondary endpoints such as pain intensity compared with initial level during the whole study also favored the HA arm. Although dressings were changed every day, these results suggest that HA might have a favorable impact on wound-related pain and on patients’ quality of life.