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24 Participants NeededMy employer runs this trial

Nu-3 Gel for Foot Ulcer

Recruiting at 5 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Lakewood-Amedex Inc
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Are You a Good Fit for This Trial?

This trial is for adults with Type 1 or Type 2 diabetes who have a mild, superficial foot ulcer (grade 1) that shows signs of infection but does not go deeper than the skin. The ulcer must be on or below the ankle and meet certain size and blood flow requirements. Participants need to use contraception if they could become pregnant.

Inclusion Criteria

2. Voluntary written informed consent, including information about the provisions of the Health Insurance Portability and accountability act (HIPAA) as applicable.
2. Ankle Branchial Index (ABI) between 0.9 and 1.3 within 3 months of Screening using the extremity with the target ulcer.
1. Dorsal transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 40 mmHg
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What Are the Treatments Tested in This Trial?

Interventions

  • Nu-3

Trial Overview

The study tests Nu-3 gel, an antimicrobial drug applied directly to mildly infected diabetic foot ulcers at three different dose levels. Researchers want to see which dose works best and how safe it is by comparing results after one or two weeks of treatment.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: 5mg doseExperimental Treatment1 Intervention
Group II: 2.5mg doseExperimental Treatment1 Intervention
Group III: 10mg doseExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Lakewood-Amedex Inc

Lead Sponsor

Trials
3
Recruited
90+

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