Diabetic Foot InfectionPhase 2NCT06020235
Nu-3 Gel for Infected Diabetic Foot Ulcers
A Phase 2 study testing 5% Nu-3 gel and 10% Nu-3 gel in people with Diabetic Foot Infection, run by Lakewood-Amedex Inc.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Infection
- What is being tested?
- 5% Nu-3 gel and 10% Nu-3 gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Dec 2025to Aug 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Dorsal transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 40 mmHg
Show all 15Show fewer
- 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.
- 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:
- 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.
- 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, 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.
Who cannot join
- 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 complication 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 and whose infection is improving in response to treatment.
- 6. Subject has received a systemic antibiotic within 48 hours prior to Screening.
- 7. Concurrent or expected to require systemic antimicrobials during the 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.
Show all 11Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate Safety and Antimicrobial Efficacy of Topically Once or Twice Daily Applied Bisphosphocin® Nu-3 Gel At 5% and 10% Concentrations to Infected Diabetic Foot Ulcers (iDFU)
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.
- Conditions
- Diabetic Foot Infection
- Being tested
- 5% Nu-3 gel, 10% Nu-3 gel, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% Nu-3 gelDrug
The gel is called Nu-3 which is either applied once per day or twice per day to the infected ulcer.
10% Nu-3 gelDrug
The gel is called Nu-3 which is either applied once per day or twice per day to the infected ulcer.
PlaceboDrug
Placebo gel is either applied once per day or twice per day to the infected ulcer.
| Study group | Role | What they receive |
|---|---|---|
| 5% Nu-3 gel once daily | Experimental | The 5% Nu-3 gel is applied once per day and placebo is applied once per day. Receives: Drug: 5% Nu-3 gel; Drug: Placebo |
| 5% Nu-3 gel twice daily | Experimental | The 5% Nu-3 gel is applied twice per day. Receives: Drug: 5% Nu-3 gel |
| 10% Nu-3 gel once daily | Experimental | The 10% Nu-3 gel is applied once per day and placebo is applied once per day. Receives: Drug: 10% Nu-3 gel; Drug: Placebo |
| 10% Nu-3 gel twice daily | Experimental | The 10% Nu-3 gel is applied twice per day. Receives: Drug: 10% Nu-3 gel |
| Placebo | Placebo comparator | The placebo is applied twice per day. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Number of AEs overall and those assessed by the investigators as possibly, probably, and definitely related to the study drug; number of SAEs per patient and cohort
Measured: Day 0 to Day 28
Efficacy
The rate of reduction in CFUs by >=2 logs per pathogen identified as typical and highly suspicious for being the cause of the infection, in each treatment group compared to placebo group at Day 7 compared to Day 0, and Day 14 compared to Day 0.
Measured: Day 0 to Day 14
Secondary outcomes (5)
Treatment failure rate per treatment regimen
The proportion of patients whose infection was not cured, defined as resolution of all wound infection signs, or whose infection did not improve over the course of the study defined as a lower number of clinical signs of infection or lower extent or severity as assesed by wound infection score.
Measured: Day 0 to Day 14
Treatment failure rate per treatment regimen
Number of treatment failures, defined as need to switch to oral antibiotic treatment based on clinical wound-infection assessment by the PI, per cohort
Measured: Day 0 to Day 14
Safety
Number of AEs (overall and those assessed by the investigators as possibly, probably and definitely related to the study drug) and SAEs per patient and cohort and clinically relevant changes in physical examination, vital signs, laboratory and/or ECG measurements at the defined timepoints compared to baseline
Measured: Day 0 to Day 28
Safety
Change in parameters indicative of skin irritation and/or skin sensitization compared to baseline
Measured: Day 0 to Day 28
Pharmacokinetics
Maximum concentration in the first 20 patients sampled for PK across all dosing groups after initial and repeated dosing
Measured: Day 0 to Day 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study startDec 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lakewood-Amedex Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06020235
- Sponsor's protocol ID
- LAI-Nu-3-CLIN004
- Status last verified
- Mar 2025
- First submitted
- 8 Aug 2023
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate Safety and Antimicrobial Efficacy of Topically Once or Twice Daily Applied Bisphosphocin® Nu-3 Gel At 5% and 10% Concentrations to Infected Diabetic Foot Ulcers (iDFU)
- ClinicalTrials.gov ID
- NCT06020235
- Acronym / sponsor ID
- LAI-Nu-3-CLIN004
- Conditions
- Diabetic Foot Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Lakewood-Amedex IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 31 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 5% Nu-3 gel once daily | Experimental | Drug: 5% Nu-3 gel, Drug: PlaceboThe 5% Nu-3 gel is applied once per day and placebo is applied once per day. |
| 5% Nu-3 gel twice daily | Experimental | Drug: 5% Nu-3 gelThe 5% Nu-3 gel is applied twice per day. |
| 10% Nu-3 gel once daily | Experimental | Drug: 10% Nu-3 gel, Drug: PlaceboThe 10% Nu-3 gel is applied once per day and placebo is applied once per day. |
| 10% Nu-3 gel twice daily | Experimental | Drug: 10% Nu-3 gelThe 10% Nu-3 gel is applied twice per day. |
| Placebo | Placebo comparator | Drug: PlaceboThe placebo is applied twice per day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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)
- 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.
- 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.
- 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.
Key exclusion criteria (11 listed)
- 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 complication 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 and whose infection is improving in response to treatment.
- 6. Subject has received a systemic antibiotic within 48 hours prior to Screening.
- 7. Concurrent or expected to require systemic antimicrobials during the 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5% Nu-3 gelThe gel is called Nu-3 which is either applied once per day or twice per day to the infected ulcer. | Drug | 5% Nu-3 gel once daily, 5% Nu-3 gel twice daily |
| 10% Nu-3 gelThe gel is called Nu-3 which is either applied once per day or twice per day to the infected ulcer. | Drug | 10% Nu-3 gel once daily, 10% Nu-3 gel twice daily |
| PlaceboPlacebo gel is either applied once per day or twice per day to the infected ulcer. | Drug | 10% Nu-3 gel once daily, 5% Nu-3 gel once daily, Placebo |
Primary outcome
Safety
Time frame: Day 0 to Day 28
Number of AEs overall and those assessed by the investigators as possibly, probably, and definitely related to the study drug; number of SAEs per patient and cohort
Efficacy
Time frame: Day 0 to Day 14
The rate of reduction in CFUs by >=2 logs per pathogen identified as typical and highly suspicious for being the cause of the infection, in each treatment group compared to placebo group at Day 7 compared to Day 0, and Day 14 compared to Day 0.
5 secondary outcomes
Treatment failure rate per treatment regimen
Time frame: Day 0 to Day 14
Treatment failure rate per treatment regimen
Time frame: Day 0 to Day 14
Safety
Time frame: Day 0 to Day 28
Safety
Time frame: Day 0 to Day 28
Pharmacokinetics
Time frame: Day 0 to Day 13
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Diabetic Foot Infection
Recruiting
Continuous Monitoring of Plantar Temperature Variations Using Connected Insoles and a Mobile Application for Diabetic Foot.
Diabetic Foot Disease, Diabetic Foot Infection
RecruitingPhase 3
Safety and Efficacy Study of Contezolid Acefosamil and Contezolid Compared to Linezolid Administered Intravenously and Orally to Adults With Moderate or Severe Diabetic Foot Infections (DFI)
Diabetic Foot Infection
Not yet recruitingObservational study
18F-FDG PET/CT for Diagnosis of Diabetic Foot Osteomyelitis
Diabetic Foot Infections
Active, not recruiting
Randomized Double-Blind Trial on Safety and Efficacy of Nanordica Advanced Antibacterial Wound Dressing for Diabetic Foot Ulcer
Diabetic Foot Ulcer, Diabetic Foot Infection
RecruitingPhase 2
Phase 2a Dose Finding Study of Nu-3 Gel in Subjects With Mild iDFU
Diabetic Foot Ulcers (DFUs)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 5% Nu-3 gel and 10% Nu-3 gel in people with Diabetic Foot Infection, run by Lakewood-Amedex Inc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Balzer (941-225-2516 ext. 108, tbalzer@lakewoodamedex.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: Day 0 to Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.