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

Inclusion Criteria:

• In the opinion of the Investigator, the subject is capable of understanding and complying with protocol requirements
• The subject or, when applicable, the subject's legally acceptable representative signs and dates a written, informed consent form (ICF) and/or any required privacy authorization prior to the initiation of any study procedures
• Subjects aged 18 to 95 years, inclusive, with Type 1 or Type 2 diabetes undergoing therapy for glycemic control
• Subjects having single or up to two wounds, minimum 4.0 cm apart, below knee ulcer of at least 4 week duration which is a full thickness ulcer without exposure of bone, muscle, ligaments, or tendons
• Ulcer should be clinically non-infected as determined by clinical examination and complete hemogram and serum creatinine
• Ulcer area (length x width) measurement between 1.5 cm2 and 10 cm2, inclusive 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
• If Charcot deformity is present, it should be free of acute changes and in the opinion of Investigator, should have undergone appropriate structural consolidation
• Doppler waveform consistent with adequate flow in the foot (biphasic or triphasic waveforms) at Screening
• Inability to perceive 10 grams pressure using Semmes-Weinstein 5.07 monofilament in the peri-ulcer area
• Ankle Brachial index between 0.9 and 1.2
• All individuals of childbearing potential must agree to use a method of contraception deemed acceptable by the Investigator or agree to remain abstinent throughout the study

Exclusion Criteria:

• Actively infected ulcers with or without purulent discharge, ulcers with exposed bone or associated with osteomyelitis. The osteomyelitis should be ruled out by clinical examination and X-ray findings where found necessary by the Investigator
• Subjects having cellulitis, ischemic or gangrenous ulcers in the opinion of the Investigator
• Patients on any other treatment modality for Diabetic Foot ulcers
• Intolerance to beta blockers at any time in the past
• A history of alcohol or drug abuse within the last 3 months
• Glycosylated hemoglobin (HbA1C) >12%, fasting blood glucose levels >130mg/dL and post prandial blood glucose levels >180 mg/dL
• Foot ulcer caused primarily by untreated vascular insufficiency, or ulcer with an etiology not related to diabetes
• Women that are pregnant or lactating
• Diagnosed and/ currently unstable hypotension, heart block, cardiac failure, and other cardiac complications as evidenced by electrocardiogram (ECG) or 2 dimensional echocardiogram (2D ECHO) findings duly consulted with Cardiologist
• Subject with bronchospastic disease
• Subject diagnosed with cancer undergoing chemotherapy
• Received another investigational drug or biologic within 30 days prior to signing the ICF or currently participating in an investigational drug or biologic study
• 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
• Unwillingness to participate
• 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
• Subjects who are being administered catecholamine depleting drugs eg. reserpine
• The subject should be homeless