Nu-3 Topical Gel for Treatment of Diabetic Foot Ulcer

NCT05276401 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: LLA-Nu-3-CLIN002
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 5

Brief 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)

Conditions

Chronic Diabetic Foot Ulcers

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

Outcome Measures

Primary Outcomes (1)

• 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

  28 days

Study Arms (2)

Active

EXPERIMENTAL

Dosage Form: Topical Antimicrobial Gel; Dosage: 5% Gel, 10% Gel; Frequency: BID for 28 days

Drug: 5% Bisphosphocin Topical Gel; Drug: 10% Bisphosphocin Topical Gel

Placebo

PLACEBO COMPARATOR

Dosage Form: Topical Gel; Dosage: Placebo; Frequency: BID for 28 days

Drug: Placebo Topical Gel

Interventions

5% Bisphosphocin Topical Gel DRUG

Topical Gel

Also known as: 5% Nu-3 Topical Gel

Active

Placebo Topical Gel DRUG

Topical Gel

Also known as: Placebo

Placebo

10% Bisphosphocin Topical Gel DRUG

Topical Gel

Also known as: 10% Nu-3 Topical Gel

Active

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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before performance of any clinical investigation-related procedure, and with the understanding that consent may be withdrawn at any time without prejudice to future medical care.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.
• 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:
• a. 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Lakewood-Amedex Inc: lead
• Professional Education and Research Institute: collaborator
• PrimeVigilance: collaborator

Study Sites (5)

NEA Baptist Clinic

Jonesboro, Arkansas, 72405, United States

Location

Limb Preservation Platform, Inc.

Fresno, California, 93710, United States

Location

Doctors Research Network

South Miami, Florida, 33143, United States

Location

ACM Global Laboratories

Rochester, New York, 14624, United States

Location

Futuro Clinical Trials, LLC

McAllen, Texas, 78501, United States

Location

MeSH Terms

Conditions

Diabetic Foot; Metabolic Diseases; Skin Ulcer; Diabetic Angiopathies; Foot Ulcer; Diabetic Neuropathies; Cardiovascular Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Endocrine System Diseases; Skin Diseases; Diabetes Complications; Vascular Diseases; Leg Ulcer

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Nutritional and Metabolic Diseases; Foot Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: Dr. Adam Ruskin
• Organization: Lakewood Amedex

ARuskin@LakewoodAmedex.com

941-225-2514

Study Officials

• Sumita Paul, MD, MPH

  Lakewood-Amedex Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-Blind
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: March 11, 2022
• Study Start: March 11, 2022
• Primary Completion: May 18, 2022
• Study Completion: June 15, 2022
• Last Updated: January 30, 2024
• Results First Posted: January 30, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)