Clinical trials

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Condition / disease
Location
Status: Not yet recruiting

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

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

Participants needed: 24
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Lakewood-Amedex IncUpdated: May 4, 2026
Eligibility criteria

Male and female subjects ≥18 years of age. [+9]

Ulceration with exposed tendon, capsule, or bone [+20]

Status: Not yet recruiting

Nu-3 Gel for Infected Diabetic Foot Ulcers

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.

Participants needed: 60
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Lakewood-Amedex IncUpdated: Mar 6, 2025
Eligibility criteria

1. Male and female subjects ≥18 years of age. 2. Voluntary written informed cons... [+3]

1. Ulceration with exposed tendon, capsule, or bone 2. IDSA-defined moderate or...