TOPLINE:
METHODOLOGY:
- Standard wound care for diabetic foot ulcers involves vascular assessment, surgical debridement, use of appropriate dressings, infection management, and glycemic control; however, standard care is typically associated with poor outcomes.
- Researchers conducted a multicenter clinical trial in 15 tertiary care centers with diabetic foot units across France, Italy, Germany, and Sweden to evaluate the efficacy and safety of intact fish skin grafts over standard-of-care practices in treating complex diabetic foot ulcers.
- A total of 255 patients aged 18 years or older with diabetes and lower limb wounds penetrating to the tendon, capsule, bone, or joint were randomly assigned to receive either an intact fish skin graft or standard wound care for 14 weeks.
- The primary endpoint was the percentage of wounds achieving complete closure by 16 weeks.
- Wound healing was also assessed at 20 and 24 weeks.
TAKEAWAY:
- The proportion of wounds healed at 16 weeks was higher with intact fish skin grafts than with standard-of-care (44.0% vs 26.4% adjusted odds ratio [aOR], 2.58; 95% CI, 1.48-4.56).
- The fish skin grafts continued to be more effective than standard wound care practices at weeks 20 (aOR, 2.15; 95% CI, 1.27–3.70) and 24 (aOR, 2.19; 95% CI, 1.31–3.70).
- The mean time to healing was 17.31 weeks for the intact fish skin graft group and 19.37 weeks for the standard-of-care group; intact fish skin grafts were also associated with faster healing times than standard wound care (hazard ratio, 1.59; 95% CI, 1.07-2.36).
- Target wound infections were the most common adverse events, occurring in a similar number of patients in both the groups.
IN PRACTICE:
“Our trial demonstrated treatment of complex diabetic foot ulcers with intact fish skin grafts achieved a significantly greater proportion of diabetic foot ulcers healed at 16 weeks than standard of care, and was associated with increased healing at 20 and 24 weeks. That these results were achieved in non-superficial UT [University of Texas diabetic wound classification system] grade 2 and 3 diabetic foot ulcers and included ischemic and/or infected diabetic foot ulcers is of importance,” the authors wrote.
SOURCE:
The study was led by Dured Dardari, MD, PhD, Center Hospitalier Sud Francilien, Corbeil-Essonnes, France, and was published online in NEJM Evidence.
LIMITATIONS:
No limitations were discussed for this study.
DISCLOSURES:
The study was funded by European Commission Fast Track to Innovation Horizon 2020 and Kerecis. Two authors reported being employees with or without stock options at Kerecis, and other authors reported having ties with many sources including Kerecis.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.