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Nu-3 Gel for Infected Diabetic Foot Ulcers

NCT06020235 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-03-06

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Lakewood-Amedex Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2026-06-30
Completion
2026-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06020235 on ClinicalTrials.gov