Phase 2a Dose Finding Study of Nu-3 Gel in Subjects With Mild iDFU (NCT07565506) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Phase 2a Dose Finding Study of Nu-3 Gel in Subjects With Mild iDFU
24 participantsStarted 2026-08
Plain-language summary
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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Non-hospitalized ambulatory subjects diagnosed with diabetes mellitus, Type I or II per ADA criteria with signs of a localized mild foot infection as defined by the IDSA infection severity criteria (Lipsky,2012). The presence of purulent drainage or at least two of the following criteria:
. 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.
. Adequate vascular perfusion as evidenced by one of the following:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Primary Efficacy Outcome
Timeframe: From enrollment to the end of day 7 and at the end of treatment at day 14
2
Primary Safety Outcome
Timeframe: From enrollment to the end of study participation at 4 weeks
. 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.
Exclusion criteria
. 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
. Subject is currently receiving topical antimicrobial treatment for a localized infection of the study ulcer or received such topical antimicrobial treatment \< 72 hours prior to study enrollment.
. Subject has received systemic treatment with a long-lasting antibiotic such as azathioprine (within less than 10 days prior to Screening) or any other systemic antibiotic within 48 hours prior to Screening.
. Concurrent or expected to require systemic antimicrobials during the active treatment study period for any infection including diabetic foot ulcer.
. Any subject that has active viral hepatitis (A, B, C) and/or untreated HIV/AIDS.