medwireNews: The use of esmolol hydrochloride in adults with diabetic foot ulcers improves wound healing and may constitute a novel treatment option, suggests research reported at the 58th EASD Annual Meeting in Stockholm, Sweden.
The phase 3 study included people with diabetes from 27 centers in India who had a non-infected full thickness diabetic foot ulcer with a duration of over 4 weeks and size of 2–15 cm2. In all, 68 participants were randomly assigned to receive esmolol hydrochloride 14% gel plus standard of care and 72 were given standard of care only.
The proportion of individuals achieving complete wound closure during the 12-week treatment phase was significantly higher in the esmolol group than in the standard of care group, at 60.3% versus 41.7%, respectively, and an odds ratio (OR) of 2.12.
A total of 57 individuals in the esmolol group and 63 in the standard of care group completed the 24-week study, and similarly, the proportion of people achieving target ulcer closure at the end of week 24 was significantly higher in the esmolol group than in the standard of care group, at 77.2% versus 55.6% (OR=2.70).
Furthermore, a subgroup analysis showed that esmolol was superior to standard of care regardless of the site and the size of the ulcer.
However, presenter Ashu Rastogi (Post Graduate Institute of medical Education and Research, Chandigarh, India) said that both the esmolol and control groups had a similar average time for ulcer closure (74.3 vs 72.5 days).
In terms of safety, 13.2% of people given esmolol and 18.4% of those given standard care alone experienced adverse events (AEs). The presenter told delegates that all the serious AEs (n=1) and the majority of AEs (n=21) in the esmolol arm were not related to the medication, indicating a favorable safety profile.
An audience member, who is part of the group reviewing all of the studies for the next international consensus guidelines for management of wound healing, congratulated Rastogi and team for this “astounding” result, noting that “this is way beyond anything that has been shown so far with any medication or intervention.”
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EASD Annual Meeting; Stockholm, Sweden: Sept 19–23, 2022