Diabetic Foot Infections Clinical Trial
Official title:
A Phase I/IIa, Randomized Double Blind, Placebo-Controlled, Dose Escalating Study to Evaluate the Safety and Tolerability of Topically Applied Bisphosphocin Nu-3 on Infected Diabetic Ulcers of Subjects With Type I or II Diabetes Mellitus
Phase I/IIa, five cohort ascending dose with two dosing arms per cohort, study in Type I or II diabetes mellitus subjects with a chronic infected diabetic ulcer defined as having a DUSS score of 0 to 3 and DFI wound score of 1 to 3.
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.
;
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N/A |