Topically Applied Bisphosphocin Nu-3 on Infected Diabetic Ulcers of Subjects With Type I or II Diabetes Mellitus

The study is designed to run the cohorts in series with the completion of the first cohort
before initiating the next dosing level. At all study visits the ulcer will be visually
examined for any changes and photographed using the Aranz Medical Silhouette™ system that
will calculate area and depth of the ulcer.

In Arm 1, eligible subjects will be treated with a single application of Nu-3 or placebo in
4 to 1 ratio to judge the initial safety of Nu-3 over a brief one (1) hour interval and
24-hr interval post application. Bisphosphocin Nu-3 will be applied topically to the chronic
infected ulcer, covered with a non-abrasive bandage following the initial observation
period. The subject will be released with verbal instructions to leave the bandage on the
wound and return for a follow up visit within 24h ± 2h. At the follow up visit, the bandage
will be removed, the ulcer visually examined and the subject cleared for the MAD Arm 2 based
on the recommendation of the PI and absence of any SAEs.

In Arm 2, eligible subjects which are those who have been approved by the PI after the Visit
2 examination will be instructed in the proper application of bisphosphocin Nu-3. The
subjects will be observed applying the first dose in the clinic to ensure compliance.
Subjects will then be given a 7 day supply and sent home to continue treatment. Visit 4 or
earlier in the case of any adverse events, subjects will return to the clinic for an
examination, including visual examination of the ulcer, vital signs, adverse events, photo
documentation, collection of a sample for microbiology and concomitant medication use. A
final follow up visit will be scheduled +7 days after last dose of study medication (Day 15)
for a complete examination as described above.

Inclusion Criteria:

1. Signed Informed Consent Form must be obtained for the subject and if necessary the
subject's caregiver prior to any study related procedures being performed

2. Non-hospitalized ambulatory subjects suffering from Diabetes mellitus, Type I or II

3. Male or Female older than 18 yrs

4. Diabetic foot ulcer(s) with a DUSS Score of 0 to 3

5. A radiograph, MRI, and/or CAT scan evaluation within the last seven (7) days to
determine the ulcer is not caused by an osteomyelitic bone infection

6. Infection as defined by the IDSA as ≥ 2 classic findings of inflammation or purulence

7. Ulcerated area(s) of not more than two (2) ulcers between 0.5 to 6 cm2 as calculated
by the Aranz Medical Silhouette™ system

8. Infection must be localized to the area of the ulcer and defined as mild (superficial
and limited in size and depth) with a DFI Wound Score between 1 and 6

9. Subject must agree to be treated as an outpatient, follow all protocol procedures,
return for all schedule visits, and provide informed consent

10. Any female of child bearing age must consent to use medically acceptable birth
control for the duration of the study

Exclusion Criteria:

1. A DUSS Score above 3

2. Any ulcer caused by an underlying osteomyelitic bone infection

3. Assessed with a Moderate to Severe Infection, including abscesses, extensive
gangrene, symptoms of systemic infection, or a limb threatening infection. DFI Wound
Score above 6

4. Hemoglobin A1c (HbA1c) level ≥ 9.0%

5. An ulcer area(s) greater than 6 cm2 or more than two (2) ulcers

6. Any subject that has received systemic or topical antibiotics within the last seven
(7) days

7. Any subject on topical antimicrobial treatment for their infected diabetic foot ulcer
whose ulcer is responding to treatment

8. Any subject that would be unable to follow the protocol procedures, safely monitor
the infection status at home, and return for schedule visits

9. Positive pregnancy test at Screening or Visit 2

10. Positive drug or alcohol test at Screening Visit or Visit 2, unless determined by the
Principal Investigator (PI) the positive result would not impair full participation
in the clinical research study