Nu-3 Gel for Infected Diabetic Foot Ulcers
ConditionDiabetic Foot Infection
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLakewood-Amedex Inc
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Male and female subjects ≥18 years of age. 2. Voluntary written informed consent, including information about the provisions of the Health Insurance Portability and accountability act (HIPAA) as applicable.
Dorsal transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 40 mmHg
Ankle Branchial Index (ABI) between 0.9 and 1.3 within 3 months of Screening using the extremity with the target ulcer.
Arterial Doppler ultrasound evaluating for biphasic or triphasic dorsalis pedis and posterior tibial vessels at the level of the ankle or a TBI (Toe Brachial Index) of >0.75.
Disqualifiers
1. Ulceration with exposed tendon, capsule, or bone 2. IDSA-defined moderate or severe DFU infection. 3. Infected diabetic foot ulcer that is associated with local wound complication such as prosthetic materials or protruding surgical hardware.
Trial design
Design model
Parallel
Treatments tested in this trial
5% Nu-3 gel
DrugThe gel is called Nu-3 which is either applied once per day or twice per day to the infected ulcer.
10% Nu-3 gel
DrugThe gel is called Nu-3 which is either applied once per day or twice per day to the infected ulcer.
Placebo
DrugPlacebo gel is either applied once per day or twice per day to the infected ulcer.
Treatment groups
60 Participants
are divided into 5 treatment groupsGroup A: 5% Nu-3 gel once dailyExperimental treatment 2 interventions
Group B: 5% Nu-3 gel twice dailyExperimental treatment 1 intervention
Group C: 10% Nu-3 gel once dailyExperimental treatment 2 interventions
Group D: 10% Nu-3 gel twice dailyExperimental treatment 1 intervention
Group E: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 282
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 14Secondary outcomes
1
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 142
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 143
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 284
Safety
Change in parameters indicative of skin irritation and/or skin sensitization compared to baseline
Time frame
Day 0 to Day 28Other outcomes
1
Wound healing
Percentage area reduction of wound size at Day 7, Day 14, and Day 28 compared to baseline
Time frame
Day 0 to Day 282
Wound healing
Change in the 5-component clinical signs DFI score at all timepoints compared to baseline
Time frame
Day 0 to Day 283
Wound healing
Change in the overall DFI score at all timepoints compared to baseline
Time frame
Day 0 to Day 28Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: