THE SAFETY AND EFFICACY OF A PROTEOLYTIC OINTMENT IN THE TREATMENT OFCHRONIC ULCERS OF THE LOWER-EXTREMITY

Background: Elase is a widely used ointment consisting of a combinatio n of 2 proteolytic enzymes, fibrinolysin and desoxyribonuclease (DNAse ). It is said to promote debridement of necrotic and purulent debris f rom skin ulcers. Objective: Our purpose was to assess the efficacy and safety of this ointment and its components in the treatment of chroni c ulcers of the lower extremity. Methods: This was a double-blind, ran domized, prospective study of 84 patients with leg ulcers exhibiting n ecrotic and purulent debris, who were treated for 21 days with twice-d aily applications of the ointment, fibrinolysin, DNAse, of who receive d the ointment vehicle (placebo). We assessed 6 efficacy features: ulc er size, purulent exudate, necrotic tissue, erythema, pain, and overal l condition of the lesion at days 8, 15, and 21 after initiation of tr eatment. We also assessed the frequency of adverse effects. Results: A ll treatments produced some improvement in the efficacy parameters and overall condition of the ulcers by week 3, but no statistically signi ficant difference was found when compared with placebo. No serious adv erse effects were noted. A later retrospective reanalysis of the data found a statistically significant reduction of purulent exudate only a t days 3 and 7 of treatment in the group treated with the complete oin tment, but not in the other features. Conclusion: The proteolytic oint ment provides no long-term clinical benefit in reducing purulent exuda te, pain, erythema, necrotic tissue, or overall condition of chronic l eg ulcers when compared with either of its two components or placebo.