Effects of Topic Simvastatin for the Treatment of Chronic Vascular Cutaneous Ulcers: A Pilot Study.

Recent research suggests that statins might be useful in the process of wound healing, playing a positive immune-modulatory role, improving microvascular function and reducing oxidative stress. The aim of this pilot study was to evaluate the efficacy of topic application of Simvastatin-based cream in the treatment of chronic vascular cutaneous ulcers, comparing this type of treatment to a collagen-based dressing, proven to be effective for ulcer treatment. A total of 20 ulcers were studied in 2 Groups of randomly-chosen patients for a period of one month. In the first Group a 0.5% Simvastatin-based cream was topically administered, while the second Group (control) was treated with an absorbable type I bovine collagen-based medication. Each week, wound healing progress was observed in both Groups, and the ulcers photographed. Wound healing rate was calculated by considering the absolute change in area and by the formula "healing ratio (%) = [(Area0 - Areat4)/Area0] × 100," both sets of data being related to the days comprised in the study in order to calculate healing rate per day. Statistical analysis was performed by Student t test. Study endpoint equaling the time-course changes of ulcer areas. At the end of the study, when considering absolute change in area, the experimental Group appeared to heal better and faster than the control Group although differences between the Groups were not statistically significant. Conversely, rates of wound healing in the experimental and control Groups were 46.88% and 64% respectively, revealing statistically significant differences. (P < 0.05). In conclusion, topic application of a simvastatin-based cream proved to be well- tolerated but not effective in the management of vascular leg ulcers in a 4 week-period.