The SANTYL Ointment (SO) group showed a statistically significant reduction in wound area from baseline at the end of treatment phase
The SO group required only 1.0 debridement (at baseline) over the course of the entire study
During the post-treatment follow-up period zero sharp debridements in the SO group were performed
|Tallis A, et al. (2013)19|
|Objective||Compare the clinical effectiveness of SANTYL Ointment with that of wet-to-dry debridement (saline-moistened gauze, SMG) plus periodic sharp debridement on diabetic foot ulcers.|
|Primary endpoint||Evaluate percent decrease in wound area at four weeks and at 12 weeks.|
|Limitations||The decision to perform sharp debridement was left to the subjective judgment of individual investigators.|
|Wound assessment scores||No significant differences were found in mean wound assessment total scores between the wet-to-dry SMG group and the SO group.|
Number of subjects
48 patients with DFUs
(prospective, parallel group, open-label, multicenter, randomized)
Two equally-sized groups:
There was one instance of sharp debridement after the treatment phase in the SO group; this did not affect the mean
Important Safety Information:Use of SANTYL Ointment should be terminated when debridement is complete and granulation tissue is well established.
One case of systemic hypersensitivity has been reported after 1 year of treatment with collagenase and cortisone. Occasional slight transient erythema has been noted in surrounding tissue when applied outside the wound.