RecruitingPhase 2NCT07565506

Phase 2a Dose Finding Study of Nu-3 Gel in Subjects With Mild iDFU

A Prospective, Randomized, Single-Blind Phase 2a Multi-Center Dose Comparative Study to Evaluated The Safety, Tolerability, and Antimicrobial Efficacy Of Topically Twice Daily Applied Bisphosphocin Nu-3 Gel At a 2%, 5%, And 10% Concentration To Infected Diabetic Foot Ulcers (iDFU)


Sponsor

Lakewood-Amedex Inc

Enrollment

24 participants

Start Date

Aug 14, 2026

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Antimicrobial agent for people with diabetic foot ulcers (dfus). The study is currently recruiting participants at 6 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAntimicrobial agent

Topical antimicrobial gel application twice a day for 2 weeks


Locations(6)

Clemente Clinical Research

Los Angeles, California, United States

First Excellent Research Group, LLC

Doral, Florida, United States

D&H Pompano Research Center

Margate, Florida, United States

New Phase Clinical Trials

Miami Beach, Florida, United States

Comprehensive Medical & Research Center

Plantation, Florida, United States

Novel Research LLC

Bellaire, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07565506


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