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

NCT07565506 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: LAI-Nu3-CLIN005
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Diabetic Foot Ulcers (DFUs)

Keywords

diabetic foot ulcer; infection; mildly infected diabetic foot ulcer; iDFU

Outcome Measures

Primary Outcomes (2)

• Primary Efficacy Outcome

  The rate reduction in CFUs by ≥ 2 logs per pathogen, which is identified as typical and highly suspicious for being the cause of the infection compared to baseline.

  From enrollment to the end of day 7 and at the end of treatment at day 14

• Primary Safety Outcome

  Number of AEs overall and those assessed by the investigators as possibly, probably, and definitely related to the study drug as well as the number of SAEs per patient and cohort.

  From enrollment to the end of study participation at 4 weeks

Secondary Outcomes (3)

• Treatment success by dose

  From enrollment to the end of treatment at 2 weeks

• Treatment failures by dose

  From enrollment to the end of treatment at 2 weeks

• Secondary safety outcomes

  From enrollment to 7 days of treatment, end of treatment at 2 weeks, and end of study participation in the study at 4 weeks

Other Outcomes (1)

• Wound healing by dose

  From enrollment to 7 days of treatment, end of treatment at 2 weeks, and end of study participation at 4 weeks

Study Arms (3)

2.5mg dose

EXPERIMENTAL

Twice daily application for 14 days

Drug: Antimicrobial agent

5mg dose

EXPERIMENTAL

Twice daily application for 14 days

Drug: Antimicrobial agent

10mg dose

EXPERIMENTAL

Twice daily application for 14 days

Drug: Antimicrobial agent

Interventions

Antimicrobial agent DRUG

Topical antimicrobial gel application twice a day for 2 weeks

10mg dose; 2.5mg dose; 5mg dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects ≥18 years of age.
• Voluntary written informed consent, including information about the provisions of the Health Insurance Portability and accountability act (HIPAA) as applicable.
• Non-hospitalized ambulatory subjects diagnosed with diabetes mellitus, Type I or II per ADA criteria with signs of a localized mild foot infection as defined by the IDSA infection severity criteria (Lipsky,2012). The presence of purulent drainage or at least two of the following criteria:
• i. erythema, ii. warmth, iii. pain or tenderness, iv. edema, or v. induration (The diagnosis of mild infection must be confirmed immediately following debridement at Baseline).
• The target ulcer is classified as a grade 1 ulcer according to the Wagner Scale (Wagner 1979). The ulcer is a superficial, full-thickness ulcer limited to the dermis, not extending to the subcutis. Target ulcer is \>1 cm2 and \<12 cm2 post debridement at baseline and must be no higher than the ankle, on or below the malleolus (ankle bone) with ≥50% below the malleolus.
• Adequate vascular perfusion as evidenced by one of the following:
• Dorsal transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 40 mmHg
• Ankle Branchial Index (ABI) between 0.9 and 1.3 within 3 months of Screening using the extremity with the target ulcer.
• Arterial Doppler ultrasound evaluating for biphasic or triphasic dorsalis pedis and posterior tibial vessels at the level of the ankle or a TBI (Toe Brachial Index) of \>0.75.
• Subject has a caregiver who will attend the Baseline visit (V2) and/or watch the dosing and dressing demonstration video and apply wound treatment along with study dressings for the study duration.
• Must meet one of the following criteria:
• a. Female subjects of Non-Child-Bearing Potential i. Postmenopausal for at least 1 year ii. Surgically sterilized (i.e., hysterectomy or bilateral oophorectomy more than 3 months prior to Screening) iii. Bilateral tube ligation \> 6 months prior to screening iv. A negative serum β-hCG pregnancy test at screening and no breastfeeding after the administration of the study drug.
• b. Male subjects of Non-Childbearing Potential defined as: i. Vasectomized subjects for \> 6 months prior to Screening ii. Those diagnosed as sterile by a physician. c. Females and Males of Childbearing Potential who practice an acceptable method of contraception defined as the i. Use of any form of hormonal contraceptive ii. Use of a barrier method with spermicide, condoms, intrauterine device, iii. Abstinence from sexual intercourse starting at least 60 days prior to Screening and continuing at least 14 days following the last treatment.
• Subjects must be willing to undergo all clinical investigation-related procedures, attend all required visits, and cooperate fully with the investigator and site personnel.
• Subject must be willing to wear offloading RCW, if necessary (defined as ulcer at plantar site of the foot, see Appendix 6), throughout the duration of the clinical treatment.

You may not qualify if:

• Ulceration with exposed tendon, capsule, or bone
• IDSA-defined moderate or severe DFU infection.
• Infected diabetic foot ulcer that is associated with local wound complications such as prosthetic materials or protruding surgical hardware.
• \> 1 infected foot ulcer
• Subject is currently receiving topical antimicrobial treatment for a localized infection of the study ulcer or received such topical antimicrobial treatment \< 72 hours prior to study enrollment.
• Subject has received systemic treatment with a long-lasting antibiotic such as azathioprine (within less than 10 days prior to Screening) or any other systemic antibiotic within 48 hours prior to Screening.
• Concurrent or expected to require systemic antimicrobials during the active treatment study period for any infection including diabetic foot ulcer.
• Any subject that has active viral hepatitis (A, B, C) and/or untreated HIV/AIDS.
• Any subject that has vascular compromise requiring surgical intervention or has undergone vascular reconstruction or angioplasty less than 1 month prior to randomization. Any planned surgical procedures during the study participation
• eGFR \<60 and/or subject on hemodialysis within 3 months prior to randomization.
• Hemoglobin A1c (HbA1c) \>12% within 3 months prior to randomization.
• Aspartate Aminotransferase (AST, GOT) and/or Alanine Aminotransferase (ALT, GPT) \>3.0 x the upper limit of normal and/or bilirubin \>1.5 x the upper limit of normal within 3 months prior to randomization.
• Acute active Charcot foot
• Any subject that would be unable to safely monitor the infection status at home and return for scheduled visits.
• History of immunosuppression within 3 months prior to randomization, or taking immunosuppressive agents including systemic corticosteroids, except stable daily doses of 5 mg/day or less for chronic conditions

Sponsors & Collaborators

• Lakewood-Amedex Inc: lead

MeSH Terms

Conditions

Diabetic Foot; Infections

Interventions

Anti-Infective Agents

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 4, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share