Clinical trial NCT02737722 (phase 1/phase 2, status: completed)
Conditions: diabetic foot infections
ICD codes: K94.02, K94.12, K94.22, K94.32, N99.511, A02.9, A31.0
Drugs: bisphosphocin nu-3, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          1. Men and women between the ages of 18 and 85.

          2. Voluntary written consent, given before performance of any clinical
             investigation-related procedure not part of standard medical care, and with the
             understanding that consent may be withdrawn at any time without prejudice to future
             medical care.

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

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

          5. Ulcerated area(s) of not more than two (2) ulcers between 0.5 to 6 cm2

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

          7. Female subjects must meet at least one of the following additional criteria:

               1. Surgically sterile with bilateral tubal ligation or hysterectomy.

               2. Post-menopausal for at least one year.

               3. If of child-bearing potential, practicing an acceptable method of birth control
                  for the duration of the clinical investigation as judged by the Investigator,
                  such as condoms, foams, jellies, diaphragm, intrauterine device or abstinence.

          8. Subjects willing to undergo pre-and post-clinical investigation blood collection,
             physical exams and laboratory investigations.

        Exclusion Criteria:

          1. A DUSS Score above 3.

          2. DUSS Probing to Bone = "Yes"

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

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

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

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

          7. Positive pregnancy test at Screening or Visit 2

          8. Active infection as demonstrated by temperature > 37.5 oC and clinical features of
             active infection.

          9. Known immunosuppression or taking immunosuppressive agents including systemic
             steroids.

         10. History of severe co-morbidity with expected patient survival ≤ 6 months.

         11. Pregnancy or lactation

         12. Intake of investigational drugs within 28 days prior to enrollment.

         13. History of concurrent condition that, in the Investigator's opinion, would jeopardize
             the safety of the subject or compliance with the protocol.

         14. Likely inability to comply with the protocol or cooperate fully with the investigator
             and site personnel.

         15. Unwillingness or language barrier precluding adequate understanding of the trial
             procedure or cooperation with trial site personnel.

         16. Known or suspected active abuse of alcohol, narcotics or non-prescription drugs.

         17. Other planned surgical procedures within 30 days prior to or 30 days post-index
             procedure.

         18. Prior enrollment in this clinical trial