Topical esmolol hydrochloride may be an effective treatment for diabetic foot ulcers
1. Patients with diabetic foot ulcers randomized to receive an application of topical esmolol hydrochloride in addition to standard care were observed to have an improved rate of wound closure at 12 weeks.
Evidence Rating Level: 1 (Excellent)
Diabetic foot ulcers (DFUs), a prevalent complication of diabetes, affect 15 – 25% of patients with diabetes in their lifetime and are associated with a high 5-year mortality rate of 46%. Despite optimal therapy, DFUs have poor healing potential and often recur. Esmolol hydrochloride is a gel formulation of a small-molecule drug that seeks to stimulate intrinsic wound-healing mechanisms when applied topically, but has yet to have significant clinical testing. This phase 3 randomized clinical trial aims to evaluate the safety and efficacy of topical esmolol gel for DFU wound closure. 176 patients (122 men [69.3%]; 54 women [30.7%]; mean [SD] age, 56.4 [9.0] years) with full-thickness, uninfected DFUs were recruited from 27 tertiary care centers across India from December 2018 to August 2020. Patients were randomized in a 3:3:1 ratio into three groups – esmolol, 14%, gel plus standard of care (SoC), SoC only, and vehicle plus SoC. Participants and investigators were blinded to this randomization. 18.6% (OR, 2.13; 95% CI, 1.08-4.17; P = .03) more participants achieved the primary endpoint of DFU closure within 12 weeks in the esmolol with SoC group than in the SoC only group. Regardless of the size or location of the ulcer, the esmolol with SoC group performed better and demonstrated significantly higher rates of closure in subgroups characterized by risk factors for poor wound healing such as body weight >80 kg and BMI >25. Findings suggest that topical esmolol may represent a promising new adjunctive therapy for the treatment of DFUs.
Click to read the study in JAMA Network Open
Image: PD
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