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Recruiting Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT07565506

Public ClinicalTrials.gov record NCT07565506. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 11, 2026, 8:38 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT07565506
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 2
Lead sponsor
Lakewood-Amedex Inc
Industry
Enrollment
24 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 13, 2026
Primary completion
Dec 31, 2026
Completion
Jan 31, 2027
Last update posted
Sep 1, 2026

2026 – 2027

United States locations

U.S. sites
6
U.S. states
3
U.S. cities
6
Facility City State ZIP Site status
Clemente Clinical Research Los Angeles California 90033 Recruiting
First Excellent Research Group, LLC Doral Florida 33178 Recruiting
D&H Pompano Research Center Margate Florida 33063 Recruiting
New Phase Clinical Trials Miami Beach Florida 33140 Recruiting
Comprehensive Medical & Research Center Plantation Florida 33317 Recruiting
Novel Research LLC Bellaire Texas 77401 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07565506, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 1, 2026 · Synced Sep 11, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07565506 live on ClinicalTrials.gov.

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