Nu-3 Gel for Mild Diabetic Foot Ulcers

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

Recruiting Phase 2 Interventional Study
Diabetic Foot Ulcers (DFUs)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
24 (estimated)
Sponsor
Lakewood-Amedex Inc · Industry
Who this trial is looking for

This trial is looking for adults with mild diabetic foot ulcers and type 1 or 2 diabetes. Participants will apply a gel treatment daily for 4 months and attend checkups every two weeks.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am at least 18 years old.
  • I have been diagnosed with type 1 or type 2 diabetes.
  • I have a mild foot infection with specific symptoms.
  • I have a specific size of foot ulcer.
  • I have adequate blood flow to my feet.
  • I can have a caregiver help me during the trial.
  • I agree to all study procedures and visits.
  • I have a recent foot x-ray showing no bone issues.

You may not be able to join if

  • I have a foot ulcer exposing any bones or tendons.
  • I have a moderate or severe foot infection.
  • I have more than one infected foot ulcer.
  • I received certain antibiotics recently.
  • I have active viral hepatitis or untreated HIV/AIDS.
  • I have severe kidney issues.
  • I have a high hemoglobin A1c level.
  • I have a history of drug abuse affecting my safety.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About 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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Male and female subjects ≥18 years of age. 2. Voluntary written informed consent, including information about the provisions of the Health Insurance Portability and accountability act (HIPAA) as applicable. 3. Non-hospitalized ambulatory subjects diagnosed with diabetes melli…
Contacts

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