Topical Esmolol Hydrochloride as a Novel Treatment Modality for Diabetic Foot Ulcers: A Phase 3 Randomized Clinical Trial.

ABSTRACT:

Importance

Preclinical and phase 1/2 studies with esmolol hydrochloride suggest its potential role in treatment of diabetic foot ulcers (DFUs).

Objective

To study the efficacy of topical esmolol for healing of uninfected DFUs.

Design, setting, and participants

A randomized, double-blind, multicenter, phase 3 clinical trial was conducted from December 26, 2018, to August 19, 2020, at 27 referral centers across India. Participants included adults with DFUs.

Interventions

Participants were randomized after a run-in phase (1 week) to receive esmolol, 14%, gel with standard of care (SoC), SoC only, or vehicle with SoC (3:3:1 proportion) for 12 weeks (treatment phase) and followed up subsequently until week 24.

Main outcomes and measures

The primary outcome wa

SUBMITTER: Rastogi A 

PROVIDER: S-EPMC12520708 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature