drugset / Trial / NCT07565506

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

NCT07565506 ↗

Phase 2 Not yet recruiting 24 enrolled Lakewood-Amedex Inc
RandomizedParallel-groupDouble-blindTreatment

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

Timeline

Start
2026-08
Primary completion
2026-12
Completion
2026-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Nu-3 Unknown 2 % Topical
Subject Nu-3 Unknown 5 % Topical
Subject Nu-3 Unknown 10 % Topical

Indications