Phase 3 Study to Evaluate the Safety and Efficacy of Galnobax® in Treating Diabetic Foot Ulcers

The current study is a Prospective, Multicenter, Randomized, Double-Blind, Phase 3 Study to Evaluate the Safety and Efficacy of a Gel Formulation of Esmolol Hydrochloride (Galnobax®) in Treating Diabetic Foot Ulcers. The study evaluates the safety and effectiveness of Galnobax® plus Standard of Care versus only Standard of Care, in treating Diabetic Foot Ulcers (DFU). In addition, Study is designed to investigate the safety of Galnobax® vehicle for establishing non-deleterious effects of Vehicle on wound healing in the Subjects with DFU.

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