Aim: The aim of this study was to preliminarily evaluate efficacy and tolerability of a new gel formulation in the treatment of difficult to heal leg ulcers. Methods: From June to December, 2003 8 subjects (2 male and 6 female, mean age 61, range 39-79 years) affected by difficult-to-heal leg ulcers were enrolled. 3 with venous ulcers, 2 with postsurgical ulcers, 1 with post-traumatic ulcer, 1 with ulcers and progressive systemic sclerosis, and 1 with a pressure ulcer. The test article was composed of an amorphous hydrogel containing 5% alginates and an antibacterial enzymatic complex (glucosidase and lactose-peroxidase); The treatment schedule consisted of daily application of the gel covered by a secondary non-adherent medication for 3 months.
Results: At the end of the study there was complete resolution in 5 cases and >50% improvement in 3 cases. Onset of wound healing response varied from 20 days to 3 months, with reduction of pain and no observed side effects. Advantages of the gel were: its ability to retain moisture, its significant absorbant properties, its antibacterial activity, conformatbility of the medication to the ulcer surface, reduction of pain associated with minimal to no trauma and its ease of use. Conclusion: In conclusion our results, although preliminary, suggest that the tested product is well tolerated and capable of promoting wound healing in daddition to protecting th wound from opportunistic infections.return to articles