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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Lakewood-Amedex Inc
Study ID
NCT07565506
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Diabetic Foot Ulcers (DFUs)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Antimicrobial agent — DRUG
    Topical antimicrobial gel application twice a day for 2 weeks

Study Details

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

Key Dates

First listed
May 4, 2026
Start date
Aug 14, 2026
Status verified
Aug 2026
Primary completion
Jan 31, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 2.5mg dose
    Twice daily application for 14 days
  • Experimental: 5mg dose
    Twice daily application for 14 days
  • Experimental: 10mg dose
    Twice daily application for 14 days

Primary Outcome Measure

Primary Efficacy Outcome [ Time Frame: From enrollment to the end of day 7 and at the end of treatment at day 14 ]

Locations (6)

FacilityCityStateZIPSite coordinators
Clemente Clinical ResearchLos AngelesCalifornia90033
Scott Mathis
[email protected]
949-412-8445
Stanley Mathis, DPM (PRINCIPAL_INVESTIGATOR)
First Excellent Research Group, LLCDoralFlorida33178
Ana Orozco
[email protected]
305-364-5219
Luis Mas, MD (PRINCIPAL_INVESTIGATOR)
D&H Pompano Research CenterMargateFlorida33063
Gabriel Khawam
[email protected]
786-375-6210
Maria Pena
[email protected]
Michael Sassine, DPM (PRINCIPAL_INVESTIGATOR)
New Phase Clinical TrialsMiami BeachFlorida33140
Lourdes Gonzalez
[email protected]
305-858-4300
Lesley Warren, DPM (PRINCIPAL_INVESTIGATOR)
Comprehensive Medical & Research CenterPlantationFlorida33317
Wilmer S Garcia
[email protected]
954-365-3529
Andrew Tillett
[email protected]
Mudit Jain, MD (PRINCIPAL_INVESTIGATOR)
Novel Research LLCBellaireTexas77401
Hina Arshad
[email protected]
832-834-5627
Babajide Ogunlana, DPM (PRINCIPAL_INVESTIGATOR)

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Clemente Clinical Research· Los Angeles, CAFirst Excellent Research Group, LLC· Doral, FLD&H Pompano Research Center· Margate, FLNew Phase Clinical Trials· Miami Beach, FLComprehensive Medical & Research Center· Plantation, FLNovel Research LLC· Bellaire, TX

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