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NOT YET RECRUITING
NCT06020235
PHASE2

Nu-3 Gel for Infected Diabetic Foot Ulcers

Sponsor: Lakewood-Amedex Inc

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-12

Completion Date

2026-08

Last Updated

2025-03-06

Healthy Volunteers

No

Interventions

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.