NCT06020235

Nu-3 Gel for Infected Diabetic Foot Ulcers

A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate Safety and Antimicrobial Efficacy of Topically Once or Twice Daily Applied Bisphosphocin® Nu-3 Gel At 5% and 10% Concentrations to Infected Diabetic Foot Ulcers (iDFU)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Lakewood-Amedex Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Diabetic Foot Infection

Interventions

Type	Name	Description
DRUG	5% Nu-3 gel	The gel is called Nu-3 which is either applied once per day or twice per day to the infected ulcer.
DRUG	10% Nu-3 gel	The gel is called Nu-3 which is either applied once per day or twice per day to the infected ulcer.
DRUG	Placebo	Placebo gel is either applied once per day or twice per day to the infected ulcer.

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-06-01
• Completion: 2026-08-01
• First posted: 2023-08-31
• Last updated: 2025-03-06