Efficacy of topical pale sulfonated shale oil in the treatment of venous leg ulcers:: A randomized, controlled, multicenter study

Background. Venous leg ulcers are a growing socioeconomic burden. Pale sulfonated shale oils (PSSO) are used for therapy of inflammatory skin diseases and have been shown to enhance wound healing in vitro and in vivo. The aim of this study was to investigate whether PSSO is capable of enhancing venous ulcer healing beyond compression therapy alone. Methods. One hundred nineteen patients were enrolled in this randomized, multicenter, observer-blind study. In the treatment group, PSSO 10% was applied daily for 20 weeks, and the control group received the vehicle only. Wounds were covered by a nonadherent gauze dressing, and compression therapy with short-stretch elastic bandages was performed in an outpatient setting. The primary study end point was defined as cumulative reduction in wound area; the secondary study end point was treatment success as assessed by both physicians and patients. Additionally, adverse events, including changes with respect to physical examination and vital signs, were documented. Results. At the end of the study period, ulcer size was significantly more reduced in the PSSO group compared with the vehicle group (15 +/- 15.9 to 6.2 +/- 12.9 cm(2) vs 11.4 +/- 14.5 to 10.8 +/- 15.7 cm(2); P =.0005). The cumulative relative reduction in ulcer area was significantly higher in the PSSO group (-4391 +/- 4748.7 vs -231.9 +/- 6283.6 % X days; P <.0001). Relative reduction in wound area was significantly greater in the PSSO group as early as 6 weeks after the beginning of treatment (-47.4 +/- 28.4 vs -23.8 +/- 42.2%; P <.001). PSSO was judged successful both by physicians and patients. There were no significant differences in adverse events (PSSO, 9 [12.2%]; vehicle, 7 [11.1%]. Similarly, tolerability of PSSO was equal to the tolerability of the vehicle. Conclusion: Pale sulfonated shale oils were capable of favoring venous ulcer healing in addition to compression therapy. PSSO should be considered for future wound care protocols for treatment of venous leg ulcers.