Phase 2a Dose Finding Study of Nu-3 Gel in Subjects With Mild iDFU
ConditionDiabetic Foot Ulcers (DFUs)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLakewood-Amedex Inc
About this trial
The goal of this clinical trial is to learn if drug Nu-3 works to treat mildly infected diabetic foot ulcers in adults with Type 1 or Type 2 diabetes at 3 different dose levels. It will also learn about the safety of drug Nu-3. The main questions it aims to answer are:
Does drug Nu-3 lower the number of bacteria or viruses in the infected ulcer, or cure patients of the infection, at any or all of the dose levels being tested after 1 week or 2 weeks? What medical problems do participants have when taking the topical drug Nu-3? Researchers will compare drug Nu-3 at different dose levels to see if drug Nu-3 works to treat the infected ulcers at each of the dose levels.
Participants will:
Take drug ABC or a placebo every day for 4 months Visit the clinic once every 2 weeks for checkups and tests Keep a diary of their symptoms and the number of times they use a rescue inhaler
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male and female subjects ≥18 years of age.
Voluntary written informed consent, including information about the provisions of the Health Insurance Portability and accountability act (HIPAA) as applicable.
The target ulcer is classified as a grade 1 ulcer according to the Wagner Scale (Wagner 1979). The ulcer is a superficial, full-thickness ulcer limited to the dermis, not extending to the subcutis. Target ulcer is >1 cm2 and <12 cm2 post debridement at baseline and must be no higher than the ankle, on or below the malleolus (ankle bone) with ≥50% below the malleolus.
Dorsal transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 40 mmHg
Disqualifiers
Ulceration with exposed tendon, capsule, or bone
IDSA-defined moderate or severe DFU infection.
Infected diabetic foot ulcer that is associated with local wound complications such as prosthetic materials or protruding surgical hardware.
> 1 infected foot ulcer
Trial design
Design model
Parallel
Treatments tested in this trial
Antimicrobial agent
DrugTopical antimicrobial gel application twice a day for 2 weeks
Treatment groups
24 Participants
are divided into 3 treatment groupsGroup A: 2.5mg doseExperimental treatment 1 intervention
Group B: 5mg doseExperimental treatment 1 intervention
Group C: 10mg doseExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Primary Efficacy Outcome
The rate reduction in CFUs by ≥ 2 logs per pathogen, which is identified as typical and highly suspicious for being the cause of the infection compared to baseline.
Time frame
From enrollment to the end of day 7 and at the end of treatment at day 142
Primary Safety Outcome
Number of AEs overall and those assessed by the investigators as possibly, probably, and definitely related to the study drug as well as the number of SAEs per patient and cohort.
Time frame
From enrollment to the end of study participation at 4 weeksSecondary outcomes
1
Treatment success by dose
The proportion of patients whose infection was cured, defined as resolution of all wound infection signs, or whose infection improved over the course of the study, defined as lower number of clinical signs of infection or lower extent or severity as assessed by wound infection score.
Time frame
From enrollment to the end of treatment at 2 weeks2
Treatment failures by dose
Number of treatment failures, defined as need to switch to oral antibiotic treatment based on clinical wound-infection assessment by the site PI, per cohort
Time frame
From enrollment to the end of treatment at 2 weeks3
Secondary safety outcomes
Number of clinically relevant changes in physical examination, vital signs, laboratory and/or ECG measurements at the defined timepoints compared to baseline, change in parameters indicative of skin irritation and /or skin sensitization compared to baseline, and change of pain scale score for the three cohorts
Time frame
From enrollment to 7 days of treatment, end of treatment at 2 weeks, and end of study participation in the study at 4 weeksOther outcomes
1
Wound healing by dose
Percentage area reduction of wound size, change in the 5-component clinical signs DFI score (modified to Lipsky et al 2009), and change in the overall DFI score (Lipsky et al 2009)
Time frame
From enrollment to 7 days of treatment, end of treatment at 2 weeks, and end of study participation at 4 weeksSponsors and contacts
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Source ClinicalTrials.gov