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

NCT ID
NCT07565506
Registry status
Recruiting
Study type
Not specified in the registry data
Phase
Phase 2
Sponsor
Lakewood-Amedex Inc

Overview

ClinicalTrials.gov lists this study as Recruiting.

Enrollment: 24 participants (Estimated).

What is being studied

No interventions are listed in the registry data.

Who may be eligible

Ages
Not specified in the registry data
Sex
Not specified in the registry data
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following 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 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). 4. 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. 5. Adequate vascular perfusion as evidenced by one of the following: 1. Dorsal transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 40 mmHg 2. Ankle Branchial Index (ABI) between 0.9 and 1.3 within 3 months of Screening using the extremity with the target ulcer. 3. 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. 6. 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. 7. 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. 8. Subjects must be willing to undergo all clinical investigation-related procedures, attend all required visits, and cooperate fully with the investigator and site personnel. 9. 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. 10. Subject must have plain radiograph taken at screening and prior to randomization showing no evidence of bony abnormalities consistent with osteomyelitis, or gas compatible with tissue crepitus, in the affected foot. Exclusion Criteria: 1. Ulceration with exposed tendon, capsule, or bone 2. IDSA-defined moderate or severe DFU infection. 3. Infected diabetic foot ulcer that is associated with local wound complications such as prosthetic materials or protruding surgical hardware. 4. \> 1 infected foot ulcer 5. 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. 6. 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. 7. Concurrent or expected to require systemic antimicrobials during the active treatment study period for any infection including diabetic foot ulcer. 8. Any subject that has active viral hepatitis (A, B, C) and/or untreated HIV/AIDS. 9. 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 10. eGFR \<60 and/or subject on hemodialysis within 3 months prior to randomization. 11. Hemoglobin A1c (HbA1c) \>12% within 3 months prior to randomization. 12. 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. 13. Acute active Charcot foot 14. Any subject that would be unable to safely monitor the infection status at home and return for scheduled visits. 15. 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 16. Any subject with a life expectancy ≤ 6 months 17. Use of investigational drugs within 28 days prior to screening 18. Use of Aspirin® or acetylsalicylic acid containing medication (except low-dose aspirin) \< 7 days before baseline, 19. Use of oral anticoagulants (e.g., warfarin, Xarelto® or comparable products). 20. History of concurrent condition that, in the Investigator's opinion, would jeopardize the safety of the subject or compliance with the protocol including known or suspected active abuse of alcohol, narcotics, or non-prescription drugs. 21. Prior randomization in this clinical trial, or a previous Bisphosphocin study

Study locations

6 study locations are listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: United States

  • California, United States: 1
  • Florida, United States: 4
  • Texas, United States: 1

Sample of listed locations

  • Clemente Clinical Research — Los Angeles, California, 90033, United States — Site recruitment status not specified in the registry data
  • First Excellent Research Group, LLC — Doral, Florida, 33178, United States — Site recruitment status not specified in the registry data
  • D&H Pompano Research Center — Margate, Florida, 33063, United States — Site recruitment status not specified in the registry data
  • New Phase Clinical Trials — Miami Beach, Florida, 33140, United States — Site recruitment status not specified in the registry data
  • Comprehensive Medical & Research Center — Plantation, Florida, 33317, United States — Site recruitment status not specified in the registry data
  • Novel Research LLC — Bellaire, Texas, 77401, United States — Site recruitment status not specified in the registry data

Study details

Start date
August 14, 2026
Primary completion date
January 1, 2027
First posted
May 4, 2026

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07565506
Registry last updated
September 2, 2026
QualifiedStudies registry data refreshed
September 21, 2026

View NCT07565506 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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