Topically Applied Bisphosphocin Nu-3 on Infected Diabetic Ulcers of Subjects With Type I or II Diabetes Mellitus

NCT02737722 | Completed Phase 1 Results DMC

• 1 other identifier: LAI2014-1
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 3

Brief Summary

Phase I/IIa, five cohort ascending dose with two dosing arms per cohort, study in Type I or II diabetes mellitus subjects with a chronic infected diabetic ulcer defined as having a DUSS score of 0 to 3 and DFI wound score of 1 to 3.

Conditions

Diabetic Foot Infections

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Treatment-related Treatment-emergent Adverse Events as Graded According to the Common Terminology Criteria for Adverse Events v4.02 (CTCAE)

  The severity of each adverse event, as judged by the investigator, was graded according to the CTCAE v4.02. Treatment-emergent adverse events are defined as adverse events with onset times after dosing, or pre-existing adverse events that worsened during the study.

  up to Day 15 (Visit 5)

• Number of Participants With Normal and Abnormal Cultures at Visits 2, 3, 4, and 5

  The microbiological response to bisphosphocin Nu-3 based on aerobic and anaerobic culture and sensitivity was determined by measuring the reduction of pathogenic bacteria following Nu-3 treatment. Each laboratory used their own standards to decide whether the cultures were normal or abnormal.

  Days 1, 2, 9, and 15 (Visits 2, 3, 4, and 5, respectively)

Secondary Outcomes (6)

• Mean Change From Baseline in the Diabetic Ulcer Severity Score (DUSS)

  Baseline and Day 15 (Visit 5)

• Mean Change From Baseline in the Diabetic Foot Ulcer Wound Infection Score

  Baseline; Day 15 (Visit 5)

• Mean Change From Baseline in Ulcer Area in the ITT Population

  Baseline; Day 15 (Visit 5)

• Mean Change From Baseline in the Percentage of Area Reduction for Ulcers in the ITT Population

  Baseline; Day 15 (Visit 5)

• Mean Change From Baseline in Ulcer Area in the Per-Protocol Population

  Baseline; Day 15 (Visit 5)

Study Arms (2)

Bisphosphocin Nu-3

EXPERIMENTAL

Dosage Form: Topical Antimicrobial, Dosage: 1mg/mL, 10 mg/mL, 20 mg/mL, 50 mg/mL, 100 mg/mL Frequency: QD for day 1, 2x daily for 7 days, Duration: 8 days

Drug: Bisphosphocin Nu-3

Placebo

PLACEBO COMPARATOR

Dosage Form: Diluent, Frequency: QD for day 1, 2x daily for 7 days, Duration: 8 days

Drug: Placebo

Interventions

Bisphosphocin Nu-3 DRUG

Also known as: Nu-3

Bisphosphocin Nu-3

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women between the ages of 18 and 85.
• Voluntary written consent, given before performance of any clinical investigation-related procedure not part of standard medical care, 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
• Diabetic foot ulcer(s) with a DUSS Score of 0 to 3
• Ulcerated area(s) of not more than two (2) ulcers between 0.5 to 6 cm2
• Any female of child bearing age must consent to use medically acceptable birth control for the duration of the study
• Female subjects must meet at least one of the following additional criteria:
• Surgically sterile with bilateral tubal ligation or hysterectomy.
• Post-menopausal for at least one year.
• If of child-bearing potential, practicing an acceptable method of birth control for the duration of the clinical investigation as judged by the Investigator, such as condoms, foams, jellies, diaphragm, intrauterine device or abstinence.
• Subjects willing to undergo pre-and post-clinical investigation blood collection, physical exams and laboratory investigations.

You may not qualify if:

• A DUSS Score above 3.
• DUSS Probing to Bone = "Yes"
• An ulcer area(s) greater than 6 cm2 or more than two (2) ulcers
• Any subject that has received systemic or topical antibiotics within the last seven (7) days
• Any subject on topical antimicrobial treatment for their infected diabetic foot ulcer whose ulcer is responding to treatment
• Any subject that would be unable to follow the protocol procedures, safely monitor the infection status at home, and return for schedule visits
• Positive pregnancy test at Screening or Visit 2
• Active infection as demonstrated by temperature \> 37.5 oC and clinical features of active infection.
• Known immunosuppression or taking immunosuppressive agents including systemic steroids.
• History of severe co-morbidity with expected patient survival ≤ 6 months.
• Pregnancy or lactation
• Intake of investigational drugs within 28 days prior to enrollment.
• 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.
• Unwillingness or language barrier precluding adequate understanding of the trial procedure or cooperation with trial site personnel.

Sponsors & Collaborators

• Lakewood-Amedex Inc: lead

Study Sites (3)

Center for Clinical Research, Inc.

San Francisco, California, 94115, United States

Location

Journey Research, Inc.

Oldsmar, Florida, 34677, United States

Location

Clinical Research Solutions

Franklin, Tennessee, 37067, United States

Location

Limitations and Caveats

Participants were enrolled into Cohorts 1, 2, and 3; Cohorts 4 and 5 were not enrolled because of challenges with enrolling participants. Additionally, Lakewood Amedex developed a gel formulation to be used for subsequent clinical studies.

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Lakewood Amedex

poconnor@lakewoodamedex.com

941 928 7774

Study Officials

• Steve Kates, PhD

  Lakewood-Amedex Inc

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2016
• First Posted: April 14, 2016
• Study Start: April 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: February 1, 2018
• Last Updated: November 19, 2019
• Results First Posted: November 19, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)