The goal of this clinical trial is to test a topical drug in patients with mild infections of their diabetic foot ulcer. The main questions it aims to answer are: What strength does the drug need to be in order to make the infection better? How frequently does the drug need to be applied in order to make the infection better? Participants will be asked to apply the medicine on their foot ulcer twice a day for 2 weeks and remain off of that foot during that time. Participants will receive the medication either once a day or twice a day, in either a 5% or 10% gel, or placebo. Researchers will compare the 5% and 10% gels to placebo to see if the infection improves.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
The gel is called Nu-3 which is either applied once per day or twice per day to the infected ulcer.
The gel is called Nu-3 which is either applied once per day or twice per day to the infected ulcer.
Placebo gel is either applied once per day or twice per day to the infected ulcer.
Safety
Number of AEs overall and those assessed by the investigators as possibly, probably, and definitely related to the study drug; number of SAEs per patient and cohort
Time frame: Day 0 to Day 28
Efficacy
The rate of reduction in CFUs by \>=2 logs per pathogen identified as typical and highly suspicious for being the cause of the infection, in each treatment group compared to placebo group at Day 7 compared to Day 0, and Day 14 compared to Day 0.
Time frame: Day 0 to Day 14
Treatment failure rate per treatment regimen
The proportion of patients whose infection was not cured, defined as resolution of all wound infection signs, or whose infection did not improve over the course of the study defined as a lower number of clinical signs of infection or lower extent or severity as assesed by wound infection score.
Time frame: Day 0 to Day 14
Treatment failure rate per treatment regimen
Number of treatment failures, defined as need to switch to oral antibiotic treatment based on clinical wound-infection assessment by the PI, per cohort
Time frame: Day 0 to Day 14
Safety
Number of AEs (overall and those assessed by the investigators as possibly, probably and definitely related to the study drug) and SAEs per patient and cohort and clinically relevant changes in physical examination, vital signs, laboratory and/or ECG measurements at the defined timepoints compared to baseline
Time frame: Day 0 to Day 28
Safety
Change in parameters indicative of skin irritation and/or skin sensitization compared to baseline
Time frame: Day 0 to Day 28
Pharmacokinetics
Maximum concentration in the first 20 patients sampled for PK across all dosing groups after initial and repeated dosing
Time frame: Day 0 to Day 13
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