EASD 2022: Novel Topical Esmolol Hydrochloride for Diabetic Foot Ulcer: Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicentre Study
The abstract highlights the efficacy of topical esmolol in the management of diabetic foot ulcers (DFU).
The efficacy of esmolol has been previously established in pre-clinical and phase 2 study. In this first randomized, double-blind, placebo-controlled, parallel-group, multi-centre, phase-3 study on esmolol, the efficacy of topical esmolol hydrochloride gel for uninfected DFU was investigated. The study included subjects with non-infected full thickness (UTS 1B) DFU of duration>4-week, size 2cm2-15cm2 and ABI 0.7-1.3, body mass index (BMI) of 25-26 kg/m2 and mean A1c of 8.4%-8.7%, two thirds of the ulcers were plantar, and mean ulcer duration was 40-50 weeks with Type 1 or Type 2 diabetes. They were randomized to receive Esmolol + standard of Care (SoC), SoC only, after a run phase or vehicle + SoC (3:3:1 proportion) for 12 week (treatment phase) and followed further till 24 weeks.
The proportion of wound closure within 12 weeks was the primary end point in the Esmolol + SoC and SoC only groups. After12 weeks of treatment with esmolol+SoC, 60.3% patients achieved target ulcer closure while 41.7% patients in the SoC only group achieved target ulcer closure (OR = 2·126, 95% CI 1·08-4·17, p =0·0276). At the end of the study, 77·2% subjects in Esmolol + SoC group and 55·6% subjects in SoC only group (OR = 2·708, 95% CI 1·22-5·99; p = 0·0126) achieved target ulcer closure. The mean time of ulcer closure remained similar for both the study groups.
With this first phase-3 study of esmolol, it is clear that the novel topical formulation treatment significantly improves healing of DFU compared to SoC.
Session OP 04, Oral presentation 44 European Association for the Study of Diabetes (EASD) International Congress 2022, 19th – 23rd Sept. 2022, Stockholm
