Abstract
Objective: To compare outcomes of diabetic foot ulcers (DFUs) treated with clostridial collagenase ointment (CCO) or silver-containing products, both in combination with sharp debridement as needed.Approach: One hundred two subjects with qualifying DFUs were randomized to daily treatment with either CCO or a silver-containing product for 6 weeks followed by a 4 -week follow-up period. The primary outcome was the mean percent reduction in DFU area. A secondary outcome was the incidence of ulcer infections between groups.Results: At the end of treatment, the mean percent reduction in area from baseline of DFUs treated with CCO was 62% (p < 0.0001) and with silver was 40% (p < 0.0001). The difference between groups—22%—was not statistically significant (p = 0.071). Among ulcers closed by the end of treatment, the mean time to closure was 31.1 ± 9.0 days versus 37.1 ± 7.7 days, respectively (not statistically significant). There was a numerically greater incidence of target ulcer infections in the silver group (11, 21.6%) than in the CCO group (5, 9.8%; p = 0.208). No clinically relevant safety signals were identified in either group.Innovation: CCO treatment can progress a wound toward closure. Ulcer infection prophylaxis may not be sacrificed when treating DFU with CCO in lieu of silver-containing products.Conclusion: Both CCO and silver-containing products promote significant reduction in DFU area over 6 weeks of treatment with no clinically relevant safety concerns. Mean percent reduction in lesion area was numerically (22%) but not significantly greater with CCO compared to silver, as was time to ulcer closure, with an incidence of ulcer infection at least as low as for silver-containing products.
Highlights
There are more than 22 million people in the United States with diabetes mellitus,[1] of whom up to 25%are at risk for the development of diabetic foot ulcers (DFUs).[2]
Qualifying lesions were present on any part of the plantar surface of the neuropathic foot or hallux at least 5 cm from any other DFUs, measured 0.5–10 cm[2] inclusive, were of at least 6 weeks and no more than 52 weeks duration, manifested no clinical signs or symptoms of infection, and required debridement
Twenty subjects were discontinued from the study before completion for the following reasons: 13 for adverse event, 4 for protocol deviations, and 1 each for loss to follow-up, withdrawal of consent, and nonadherence with study treatment
Summary
There are more than 22 million people in the United States with diabetes mellitus,[1] of whom up to 25%. Are at risk for the development of diabetic foot ulcers (DFUs).[2] In the a Travis A. ADVANCES IN WOUND CARE, VOLUME 7, NUMBER 10 Mary Ann Liebert, Inc
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