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

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