Clinical Investigation of Galnobax® for the Treatment of Diabetic Foot Ulcers

An Interventional, Placebo-Controlled, Randomized, Double-blinded Dose Comparison, Phase I/II Study to Determine the Safety and Efficacy of a New Gel Formulation of Esmolol Hydrochloride (Galnobax®) for the Treatment of Diabetic Foot Ulcer (DFU)

The purpose of this study is to determine safety and efficacy of a new gel formulation of Esmolol hydrochloride (Galnobax®) for the treatment of Diabetic Foot Ulcer (DFU). The study will compare number and types of adverse events occured, rates of wound closure and percentage of wounds closed in Galnobax treated groups versus placebo group.

This is an interventional, placebo-controlled, randomized, double-blinded, dose comparison, phase I/II study of Galnobax® in subjects with diabetic foot ulcers. Additionally the effect of dosage and frequency of application will also be studied . The total trial duration per subject is 25 weeks which comprises of 1 week for screening, 12 weeks of treatment and 12 weeks of follow-up.

Inclusion Criteria:

• Subjects aged 18 to 95 years, inclusive, with Type 1 or Type 2 diabetes undergoing therapy for glycemic control
• Subjects having below knee ulcer of at least 4 week and maximum of 52 weeks duration which is a full thickness ulcer without exposure of bone, muscle, ligaments, or tendons
• Ulcer should be clinically non-infected
• Ulcer area (length x width) measurement between 1.5 cm2 and 10 cm2, inclusive and post debridement ulcer area less than or equal to 12 cm2.
• Full-thickness ulcer of Grade 1 or Grade 2 as per Wagner's classification system
• Recently debrided ulcer (2 weeks prior to screening) and post debridement ulcer free of necrotic debris, foreign bodies, sinus tracts, tunneling, and undermining, comprised of healthy vascularized tissue as determined by the Investigator
• Inability to perceive 10 grams pressure using Semmes-Weinstein 5.07 monofilament in the peri-ulcer area
• Ankle Brachial index between 0.7 and 1.2

Exclusion Criteria:

• Actively infected ulcers with or without purulent discharge, ulcers with exposed bone or associated with osteomyelitis.
• Subjects having cellulitis, ischemic or gangrenous ulcers in the opinion of the Investigator
• Glycosylated hemoglobin (HbA1C) >12%
• Diagnosed and/ currently unstable hypotension, heart block, cardiac failure, and other cardiac complications
• Subject diagnosed with cancer undergoing chemotherapy
• Revascularization surgery 4 weeks prior to signing the ICF
• Renal failure as defined by serum creatinine >3.0 mg/dL or renal insufficiency requiring frequent dialysis
• Poor nutritional status as measured by serum albumin <3.0 g/dL
• Active Charcot or other structural deformity that would prevent adequate off-loading of the study foot