Intervention: Esmolol Hydrochloride
Trial phase: Phase 3
SMILES: COC(=O)CCc1ccc(OCC(O)CNC(C)C)cc1.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 76
Group description: Galnobax 14% gel along with Standard of Care (SoC) will be administered twice daily (76 subjects)

Esmolol Hydrochloride: Galnobax-14% gel application along with Standard of Care
Eligibility criteria:
Inclusion Criteria:

Subjects, male or female, aged 18 to 75 years (inclusive) with Type 1 or Type 2 diabetes undergoing therapy for glycemic control
Subject has glycosylated hemoglobin, HbA1C, ≤ 12%
Subject with diagnosis of neuropathic foot ulcer by 10g monofilament test
Subject has adequate vascular perfusion of the affected limb, confirmed by Ankle-Brachial Index (ABI) ≥ 0.65 and ≤ 1.3

Presence of at least one DFU that meets all of the following criteria:

A full-thickness ulcer of Grade A1 as per Texas classification system;
Ulcer is located below or up to 5 cm above the malleoli (excluding ulcers between the toes);
Ulcer size (area) is ≥ 2 cm2 and ≤ 15 cm2 (post-debridement);
There is a minimum 3 cm margin between the qualifying Target Ulcer and any other ulcers on the specified foot, post-debridement;
No exposed bone, tendon, muscle, ligament or joint capsule, and no tunneling, undermining, or sinus tracts;
Unresponsive to ulcer care and open for at least 6 weeks at the time of the Screening Visit;
Ulcer is non-infected as determined by clinical assessment and complete hemogram;
Ulcer has a clean, granulating base free of adherent slough to the greatest extent possible as per Investigator;
Ulcer area reduction < 30% from the Screening Visit to Baseline visit
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Investigator
Subject, if female of child-bearing potential, has a negative urine pregnancy test at Screening and willing to use acceptable methods of contraception (birth control pills, barriers) or abstinence throughout the Study
Subject is able and willing to comply with Study procedures including the use of an off-loading device (as applicable for the location of the ulcer) and adhere to protocol during the Study in the opinion of Investigator
A Subject or LAR agrees to sign informed consent form and allow audio visual recording of consent, if applicable

Exclusion Criteria:

Actively infected ulcers with or without purulent discharge, ulcers with exposed bone or associated with osteomyelitis
Subjects with more than three ulcers below knee
Subjects with Target Ulcer requiring off-loading that cannot be effectively off-loaded; or unable to tolerate the off-loading method
Subject has ulcers caused by a disease other than diabetes, e.g., fungal ulcerations, malignant ulcerations, and ulcerations due to venous or arterial insufficiency, or due to hematological disorders, in the opinion of the Investigator
Ulcer, about which the Investigator is suspicious for cancer
Subjects with a gangrenous or ischemic ulcer
Subject with ulcer that in the opinion of the Investigator, may need amputation
Subject with Target ulcer where wound measurement is not possible, such as ulcers between toes
Body mass index (BMI) > 40 kg/m2

Laboratory values at Screening of:

Hemoglobin < 10.0 g/dL
White Blood Cells (WBC) < 2.0 X 109 cells/L
Liver function studies [Total bilirubin, aspartate aminotransferase (AST) and alanine transaminase (ALT)] > 3x the upper limit of normal
Albumin < 2.5 g/dL
eGFR < 25 mL/min
Presence of any existing clinically significant medical condition(s) that, in the opinion of the Investigator, could interfere with wound healing
Subject has received or is currently receiving or scheduled to receive any medication or therapies during the course of the Study that will modulate wound healing
Subject with intolerance to β-blockers at any time in the past
Has any other factor which may, in the opinion of the Investigator, compromise participation and/or follow-up in the Study