Chronic Diabetic Foot UlcersPhase 2NCT05276401
Nu-3 Topical Gel for Treatment of Diabetic Foot Ulcer
A Phase 2 study testing 5% Bisphosphocin Topical Gel and 10% Bisphosphocin Topical Gel in people with Chronic Diabetic Foot Ulcers, run by Lakewood-Amedex Inc at 5 sites in United States.
Trial summary
A PHASE 2a, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE ESCALATING STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF TOPICALLY APPLIED BISPHOSPHOCIN NU-3 GEL TO CLINICALLY NONINFECTED CHRONIC DIABETIC FOOT ULCERS (cDFU) Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Diabetic Foot Ulcers
- What is being tested?
- 5% Bisphosphocin Topical Gel and 10% Bisphosphocin Topical Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 5 sitesUnited States
- Study dates
- 11 Mar 2022to 15 Jun 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women at least 18 years of age and up to 80 years of age, inclusive.
- Voluntary written consent, given before performance of any clinical investigation-related procedure, and with the understanding that consent may be withdrawn at any time without prejudice to future medical care.
- Non-hospitalized ambulatory subjects suffering from diabetes mellitus, Type I or II per ADA criteria.
- The target ulcer is classified as grade 1 ulcer according to a Wagner Scale. These ulcers are superficial, full-thickness ulcers limited to the dermis, not extending to the subcutis.
- Target ulcer is between 2 and 10 cm2 post debridement at screening and baseline.
- The target ulcer must be no higher than the ankle (on or below the malleolus (ankle bone) with ≥50% below the malleolus.
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- Presence of a persistent cDFU for at least 4 weeks and not more than 1 year that has failed to respond to standard of care.
- 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 0.7 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 > 0.6 is acceptable.
- Subject has a caregiver who is able to attend baseline visit and apply wound treatment and study dressings for the study duration.
- Subject completed protocol-defined standardized wound care during the Screening and Run-in periods leading up to Day 0.
- Must meet one of the following criteria:
- Female subjects of Non-Child-Bearing Potential defined as: i. Postmenopausal for at least 1 year, or surgically sterilized (i.e., hysterectomy or bilateral oophorectomy more than 3 months prior to Screening), or ii. Bilateral tubal ligation more than 6 months prior to Screening iii. Must have a negative serum β-hCG pregnancy test at screening and not be breastfeeding prior to being administered with the study drug.
- Male subjects of Non-Childbearing Potential defined as those vasectomized subjects whose vasectomy was performed 6 months prior to Screening or those diagnosed as sterile by a physician.
- Females and Males of Childbearing Potential who practice an acceptable method of contraception defined as the use of any form of hormonal contraceptive, a barrier method with spermicide, condoms, intrauterine device, or abstinence from sexual intercourse starting at least 60 days prior to Screening and continuing at least 30 days following the last treatment.
- Subjects must be willing to undergo all clinical investigation-related procedures and attend all required visits.
Who cannot join
- Ulceration with exposed tendon, capsule, or bone.
- Suspicion of bone or joint infection by clinical or other criteria.
- Unable or unwilling to utilize the standardized offloading RCW as required per protocol.
- Target ulcer has decreased in area by ≥30% between Screening (V1) and Baseline (V3) visits.
- Any subject that is currently on/requires oral, systemic or topical antibiotics, or is anticipated to require use during the course of the trial.
- 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.
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- Serum Creatinine level >3.0 mg/dL.
- Hemoglobin A1c (HbA1c) >12%.
- Aspartate Aminotransferase (AST, GOT) and/or Alanine Aminotransferase (ALT, GPT) >3x the upper limit of normal.
- Acute active Charcot foot.
- The target ulcer is within 3 cm of any other ulcer.
- Any subject that would be unable to safely monitor the infection status at home, and return for scheduled visits.
- History of immunosuppression or taking immunosuppressive agents including systemic corticosteroids, except stable daily doses of 5 mg/day or less for chronic conditions.
- Any subject with a life expectancy ≤ 6 months.
- Pregnancy, including a positive pregnancy test at Screening or Baseline, or lactation.
- Use of investigational drugs within 28 days prior to screening.
- History of concurrent condition that, in the Investigator's opinion, would jeopardize the safety of the subject or compliance with the protocol.
- Likely inability to comply with the protocol or cooperate fully with the investigator and site personnel.
- Known or suspected active abuse of alcohol, narcotics, or non-prescription drugs.
- Prior randomization in this clinical trial, or a previous Bisphosphocin study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Limb Preservation Platform, Inc.
Fresno, California, 93710
NEA Baptist Clinic
Jonesboro, Arkansas, 72405
Futuro Clinical Trials, LLC
McAllen, Texas, 78501
ACM Global Laboratories
Rochester, New York, 14624
Doctors Research Network
South Miami, Florida, 33143
About this study
Official title: A Phase 2a, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Dose Escalating Study to Evaluate the Safety and Tolerability of Topically Applied Bisphosphocin Nu-3 Gel to Clinically Noninfected Chronic Diabetic Foot Ulcers (cDFU)
A PHASE 2a, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE ESCALATING STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF TOPICALLY APPLIED BISPHOSPHOCIN NU-3 GEL TO CLINICALLY NONINFECTED CHRONIC DIABETIC FOOT ULCERS (cDFU)
Read the detailed description
This is a Phase 2a, multi-center, randomized, double-blind, placebo-controlled, dose escalation study to evaluate the safety and tolerability of twice daily (BID) topically administered concentrations of Nu-3 gel in subjects with Type 1 and 2 diabetic non-healing target chronic diabetic foot ulcer (cDFU). The study will be conducted in 4 phases: Screening, SOC Run-In, Treatment, and a Safety Follow-up.
Subjects will have the study explained to them and will be provided the study specific informed consent form (ICF). For eligible subjects, the screening evaluations will be performed after the subject provides a written informed consent. For subjects enrolled in the study, activities will consist of two visits prior to randomization: screening visit, and a run-in visit; this will be followed by six scheduled visits (total = 8 visits). Screening will commence 14 days (± 2 days) prior to baseline visit.
During the screening period, a target cDFU will be established and characterized using information obtained from the subject's medical history. At the end of the screening and the beginning of the run-in SOC periods, subjects will have their selected target lesion assessed again. Those subjects whose target ulcers are shown to have ≥ 30% decrease in area will be considered as responders and will be discontinued from the study.
Non-responder subjects will enter the active treatment period and will be randomized in a 3:1 ratio into one of these dose cohorts in a dose escalating manner:
- Cohort 1: 5% Nu-3 gel + SOC (n = 12) or placebo gel + SOC (n = 4)
- Cohort 2: 10% Nu-3 gel + SOC (n = 12) or placebo gel + SOC (n = 4)
Study drug will be applied BID to the target cDFU for 28 days (± 2 days).
The decision to dose-escalate to the next higher concentration will be based on the recommendation of the Data Monitoring Committee (DMC) that will review all of the safety data from the previous subject cohort concurrent with the safety follow-up period. This decision will be based on pre-defined Dose Limiting Toxicity criteria (DLT), which will be detailed in the DMC charter. The maximum tolerated dose (MTD) will be considered as the dose level below that for which a DLT was observed. If the criteria for a DLT occurs in the initial dosing cohort then the study will be halted.
All randomized subjects will continue to receive SOC throughout the study per Appendix 4.
After completing the active treatment period, subjects will return after 2 weeks for a follow-up safety evaluation.
- Conditions
- Chronic Diabetic Foot Ulcers
- Being tested
- 5% Bisphosphocin Topical Gel, Placebo Topical Gel, 10% Bisphosphocin Topical Gel
- Keywords
- Diabetic Foot, Metabolic Diseases, Skin Ulcer, Non-healing Wound, Diabetic Angiopathies, Foot Ulcer, Diabetic Neuropathies, Cardiovascular Diseases, Nu-3, Glucose Metabolism Disorders, DFU, Diabetes Mellitus, Endocrine System Diseases, Skin Diseases, Diabetes Complications, Non-healing Ulcer, Vascular Diseases, Leg Ulcer, Non-healing Wound Care, Bisphosphocin
- Medical subject headings
- Diabetic Foot, Metabolic Diseases, Skin Ulcer, Diabetic Angiopathies, Foot Ulcer, Diabetic Neuropathies, Cardiovascular Diseases, Glucose Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% Bisphosphocin Topical GelDrug
Also called 5% Nu-3 Topical Gel
Topical Gel
Placebo Topical GelDrug
Also called Placebo
Topical Gel
10% Bisphosphocin Topical GelDrug
Also called 10% Nu-3 Topical Gel
Topical Gel
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Dosage Form: Topical Antimicrobial Gel; Dosage: 5% Gel, 10% Gel; Frequency: BID for 28 days Receives: Drug: 5% Bisphosphocin Topical Gel; Drug: 10% Bisphosphocin Topical Gel |
| Placebo | Placebo comparator | Dosage Form: Topical Gel; Dosage: Placebo; Frequency: BID for 28 days Receives: Drug: Placebo Topical Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Assess the Number of Participants With Treatment-related Adverse Events After Nu-3 Gel Use on cDFU as Assessed by CTCAE v4.0
Treatment emergent events related to clinical investigational product
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start11 Mar 2022
- Primary completion18 May 2022
- Study completion15 Jun 2022
Why it stopped: Request for additional preclinical data.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Diabetic Foot UlcersStudies 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
- Sequential
- Model description
- Randomized
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakewood-Amedex Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Professional Education and Research Institute, PrimeVigilance
- Responsible party
- Sponsor
- Investigators
- Sumita Paul, MD, MPH, Study director, Lakewood-Amedex Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05276401
- Sponsor's protocol ID
- LLA-Nu-3-CLIN002
- Status last verified
- Dec 2023
- First submitted
- 25 Feb 2022
- Last updated
- 30 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Dose Escalating Study to Evaluate the Safety and Tolerability of Topically Applied Bisphosphocin Nu-3 Gel to Clinically Noninfected Chronic Diabetic Foot Ulcers (cDFU)
- ClinicalTrials.gov ID
- NCT05276401
- Acronym / sponsor ID
- LLA-Nu-3-CLIN002
- Conditions
- Chronic Diabetic Foot Ulcers
- Keywords
- Diabetic Foot, Metabolic Diseases, Skin Ulcer, Non-healing Wound, Diabetic Angiopathies, Foot Ulcer, Diabetic Neuropathies, Cardiovascular Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Request for additional preclinical data.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Lakewood-Amedex IncIndustry (pharma, biotech, devices)
- Collaborators
- Professional Education and Research Institute, PrimeVigilance
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 18 May 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 11 Mar 2022 (actual)
- Results
- Posted 30 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A PHASE 2a, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE ESCALATING STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF TOPICALLY APPLIED BISPHOSPHOCIN NU-3 GEL TO CLINICALLY NONINFECTED CHRONIC DIABETIC FOOT ULCERS (cDFU)
Detailed description
This is a Phase 2a, multi-center, randomized, double-blind, placebo-controlled, dose escalation study to evaluate the safety and tolerability of twice daily (BID) topically administered concentrations of Nu-3 gel in subjects with Type 1 and 2 diabetic non-healing target chronic diabetic foot ulcer (cDFU). The study will be conducted in 4 phases: Screening, SOC Run-In, Treatment, and a Safety Follow-up.
Subjects will have the study explained to them and will be provided the study specific informed consent form (ICF). For eligible subjects, the screening evaluations will be performed after the subject provides a written informed consent. For subjects enrolled in the study, activities will consist of two visits prior to randomization: screening visit, and a run-in visit; this will be followed by six scheduled visits (total = 8 visits). Screening will commence 14 days (± 2 days) prior to baseline visit.
During the screening period, a target cDFU will be established and characterized using information obtained from the subject's medical history. At the end of the screening and the beginning of the run-in SOC periods, subjects will have their selected target lesion assessed again. Those subjects whose target ulcers are shown to have ≥ 30% decrease in area will be considered as responders and will be discontinued from the study.
Non-responder subjects will enter the active treatment period and will be randomized in a 3:1 ratio into one of these dose cohorts in a dose escalating manner:
- Cohort 1: 5% Nu-3 gel + SOC (n = 12) or placebo gel + SOC (n = 4)
- Cohort 2: 10% Nu-3 gel + SOC (n = 12) or placebo gel + SOC (n = 4)
Study drug will be applied BID to the target cDFU for 28 days (± 2 days).
The decision to dose-escalate to the next higher concentration will be based on the recommendation of the Data Monitoring Committee (DMC) that will review all of the safety data from the previous subject cohort concurrent with the safety follow-up period. This decision will be based on pre-defined Dose Limiting Toxicity criteria (DLT), which will be detailed in the DMC charter. The maximum tolerated dose (MTD) will be considered as the dose level below that for which a DLT was observed. If the criteria for a DLT occurs in the initial dosing cohort then the study will be halted.
All randomized subjects will continue to receive SOC throughout the study per Appendix 4.
After completing the active treatment period, subjects will return after 2 weeks for a follow-up safety evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: 5% Bisphosphocin Topical Gel, Drug: 10% Bisphosphocin Topical GelDosage Form: Topical Antimicrobial Gel; Dosage: 5% Gel, 10% Gel; Frequency: BID for 28 days |
| Placebo | Placebo comparator | Drug: Placebo Topical GelDosage Form: Topical Gel; Dosage: Placebo; Frequency: BID for 28 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Men and women at least 18 years of age and up to 80 years of age, inclusive.
- Voluntary written consent, given before performance of any clinical investigation-related procedure, and with the understanding that consent may be withdrawn at any time without prejudice to future medical care.
- Non-hospitalized ambulatory subjects suffering from diabetes mellitus, Type I or II per ADA criteria.
- The target ulcer is classified as grade 1 ulcer according to a Wagner Scale. These ulcers are superficial, full-thickness ulcers limited to the dermis, not extending to the subcutis.
- Target ulcer is between 2 and 10 cm2 post debridement at screening and baseline.
Key exclusion criteria (20 listed)
- Ulceration with exposed tendon, capsule, or bone.
- Suspicion of bone or joint infection by clinical or other criteria.
- Unable or unwilling to utilize the standardized offloading RCW as required per protocol.
- Target ulcer has decreased in area by ≥30% between Screening (V1) and Baseline (V3) visits.
- Any subject that is currently on/requires oral, systemic or topical antibiotics, or is anticipated to require use during the course of the trial.
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% Bisphosphocin Topical GelAlso: 5% Nu-3 Topical GelTopical Gel | Drug | Active |
| Placebo Topical GelAlso: PlaceboTopical Gel | Drug | Placebo |
| 10% Bisphosphocin Topical GelAlso: 10% Nu-3 Topical GelTopical Gel | Drug | Active |
Primary outcome
To Assess the Number of Participants With Treatment-related Adverse Events After Nu-3 Gel Use on cDFU as Assessed by CTCAE v4.0
Time frame: 28 days
Treatment emergent events related to clinical investigational product
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Sumita Paul, MD, MPH study director
Lakewood-Amedex Inc
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 5% Bisphosphocin Topical Gel and 10% Bisphosphocin Topical Gel in people with Chronic Diabetic Foot Ulcers, run by Lakewood-Amedex Inc at 5 sites in United States.
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 18 inclusion and 20 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: stopped early, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 30 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Assess the Number of Participants With Treatment-related Adverse Events After Nu-3 Gel Use on cDFU as Assessed by CTCAE v4.0 (time frame: 28 days). 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 30 Jan 2024.