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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02737722
Recruitment Status : Completed
First Posted : April 14, 2016
Results First Posted : November 19, 2019
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
Lakewood-Amedex Inc

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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Infections Drug: Bisphosphocin Nu-3 Drug: Placebo Phase 1 Phase 2

Detailed Description:

The study is designed to run the cohorts in series with the completion of the first cohort before initiating the next dosing level. At all study visits the ulcer will be visually examined for any changes and photographed using the Aranz Medical Silhouette™ system that will calculate area and depth of the ulcer.

In Arm 1, eligible subjects will be treated with a single application of Nu-3 or placebo in 4 to 1 ratio to judge the initial safety of Nu-3 over a brief one (1) hour interval and 24-hr interval post application. Bisphosphocin Nu-3 will be applied topically to the chronic infected ulcer, covered with a non-abrasive bandage following the initial observation period. The subject will be released with verbal instructions to leave the bandage on the wound and return for a follow up visit within 24h ± 2h. At the follow up visit, the bandage will be removed, the ulcer visually examined and the subject cleared for the MAD Arm 2 based on the recommendation of the PI and absence of any SAEs.

In Arm 2, eligible subjects which are those who have been approved by the PI after the Visit 2 examination will be instructed in the proper application of bisphosphocin Nu-3. The subjects will be observed applying the first dose in the clinic to ensure compliance. Subjects will then be given a 7 day supply and sent home to continue treatment. Visit 4 or earlier in the case of any adverse events, subjects will return to the clinic for an examination, including visual examination of the ulcer, vital signs, adverse events, photo documentation, collection of a sample for microbiology and concomitant medication use. A final follow up visit will be scheduled +7 days after last dose of study medication (Day 15) for a complete examination as described above.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase I/IIa, Randomized Double Blind, Placebo-Controlled, Dose Escalating Study to Evaluate the Safety and Tolerability of Topically Applied Bisphosphocin Nu-3 on Infected Diabetic Ulcers of Subjects With Type I or II Diabetes Mellitus
Actual Study Start Date : April 2016
Actual Primary Completion Date : August 2017
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetic Foot

Arm Intervention/treatment
Experimental: Bisphosphocin Nu-3
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
Other Name: Nu-3

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



Primary Outcome Measures :
  1. Number of Participants With Treatment-related Treatment-emergent Adverse Events as Graded According to the Common Terminology Criteria for Adverse Events v4.02 (CTCAE) [ Time Frame: up to Day 15 (Visit 5) ]
    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.

  2. Number of Participants With Normal and Abnormal Cultures at Visits 2, 3, 4, and 5 [ Time Frame: Days 1, 2, 9, and 15 (Visits 2, 3, 4, and 5, respectively) ]
    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.


Secondary Outcome Measures :
  1. Mean Change From Baseline in the Diabetic Ulcer Severity Score (DUSS) [ Time Frame: Baseline and Day 15 (Visit 5) ]
    Clinical response to bisphosphocin Nu-3 was determined by visual evaluation of ulcers, based on the Principal Investigator's judgement, following Nu-3 treatment. Ulcers were scored based on the DUSS. The following 4 parameters were scored as either 0 or 1. Palpable pedal pulses: presence, 0; absence, 1. Probing to the bone: no, 0; yes, 1. Location of ulcer: toe, 0; foot, 1. Number of ulcerations: single, 0; multiple, 1. The four parameter scores were summed to calculate a total score ranging from 0 to 4, with a higher score indicating increased severity. Baseline is defined as the last non-missing value obtained prior to receiving study drug. Change from Baseline is calculated as the post-Baseline value minus the Baseline value.

  2. Mean Change From Baseline in the Diabetic Foot Ulcer Wound Infection Score [ Time Frame: Baseline; Day 15 (Visit 5) ]
    Change from Baseline is calculated as the post-Baseline value minus the Baseline value. Baseline is defined as the last non-missing value obtained prior to receiving study drug. The Diabetic Foot Ulcer Wound Infection Score is a numerical scoring system comprised of 7 wound parameters. The score for each individual parameter is summed to calculate a total score, ranging from 0 (less severe infection) to 19 (more severe infection). Parameters are as follows: purulent discharge (0, absent; 3, present); non-purulent discharge (serious, sanguineous) (0, absent; 1, mild); other signs and symptoms of inflammation (erythema, induration, tenderness, pain; 0, none; 1, mild; 2, moderate; 3, severe); local warmth (relative to uninfected contralateral foot) (0, same; 1, mildly increased; 2, moderately increased; 3, severely increased).

  3. Mean Change From Baseline in Ulcer Area in the ITT Population [ Time Frame: Baseline; Day 15 (Visit 5) ]
    Change from Baseline is calculated as the post-Baseline value minus the Baseline value. Baseline is defined as the last non-missing value obtained prior to receiving study drug. For participants who have more than one ulcer, the measurement of all ulcers were combined for analysis.

  4. Mean Change From Baseline in the Percentage of Area Reduction for Ulcers in the ITT Population [ Time Frame: Baseline; Day 15 (Visit 5) ]
    Change from Baseline is calculated as the post-Baseline value minus the Baseline value. Baseline is defined as the last non-missing value obtained prior to receiving study drug. For participants who have more than one ulcer, the measurement of all ulcers were combined for analysis.

  5. Mean Change From Baseline in Ulcer Area in the Per-Protocol Population [ Time Frame: Baseline; Day 15 (Visit 5) ]
    Change from Baseline is calculated as the post-Baseline value minus the Baseline value. Baseline is defined as the last non-missing value obtained prior to receiving study drug. For participants who have more than one ulcer, the measurement of all ulcers were combined for analysis.

  6. Mean Change From Baseline in the Percentage of Area Reduction for Ulcers in the Per-Protocol Population [ Time Frame: Baseline; Day 15 (Visit 5) ]
    Change from Baseline is calculated as the post-Baseline value minus the Baseline value. Baseline is defined as the last non-missing value obtained prior to receiving study drug. For participants who have more than one ulcer, the measurement of all ulcers were combined for analysis.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and women between the ages of 18 and 85.
  2. 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.
  3. Non-hospitalized ambulatory subjects suffering from Diabetes mellitus, Type I or II
  4. Diabetic foot ulcer(s) with a DUSS Score of 0 to 3
  5. Ulcerated area(s) of not more than two (2) ulcers between 0.5 to 6 cm2
  6. Any female of child bearing age must consent to use medically acceptable birth control for the duration of the study
  7. Female subjects must meet at least one of the following additional criteria:

    1. Surgically sterile with bilateral tubal ligation or hysterectomy.
    2. Post-menopausal for at least one year.
    3. 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.
  8. Subjects willing to undergo pre-and post-clinical investigation blood collection, physical exams and laboratory investigations.

Exclusion Criteria:

  1. A DUSS Score above 3.
  2. DUSS Probing to Bone = "Yes"
  3. An ulcer area(s) greater than 6 cm2 or more than two (2) ulcers
  4. Any subject that has received systemic or topical antibiotics within the last seven (7) days
  5. Any subject on topical antimicrobial treatment for their infected diabetic foot ulcer whose ulcer is responding to treatment
  6. Any subject that would be unable to follow the protocol procedures, safely monitor the infection status at home, and return for schedule visits
  7. Positive pregnancy test at Screening or Visit 2
  8. Active infection as demonstrated by temperature > 37.5 oC and clinical features of active infection.
  9. Known immunosuppression or taking immunosuppressive agents including systemic steroids.
  10. History of severe co-morbidity with expected patient survival ≤ 6 months.
  11. Pregnancy or lactation
  12. Intake of investigational drugs within 28 days prior to enrollment.
  13. History of concurrent condition that, in the Investigator's opinion, would jeopardize the safety of the subject or compliance with the protocol.
  14. Likely inability to comply with the protocol or cooperate fully with the investigator and site personnel.
  15. Unwillingness or language barrier precluding adequate understanding of the trial procedure or cooperation with trial site personnel.
  16. Known or suspected active abuse of alcohol, narcotics or non-prescription drugs.
  17. Other planned surgical procedures within 30 days prior to or 30 days post-index procedure.
  18. Prior enrollment in this clinical trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02737722


Locations
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United States, California
Center for Clinical Research, Inc.
San Francisco, California, United States, 94115
United States, Florida
Journey Research, Inc.
Oldsmar, Florida, United States, 34677
United States, Tennessee
Clinical Research Solutions
Franklin, Tennessee, United States, 37067
Sponsors and Collaborators
Lakewood-Amedex Inc
Investigators
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Study Director: Steve Kates, PhD Lakewood-Amedex Inc
  Study Documents (Full-Text)

Documents provided by Lakewood-Amedex Inc:
Study Protocol  [PDF] September 15, 2016
Statistical Analysis Plan  [PDF] August 31, 2017


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Responsible Party: Lakewood-Amedex Inc
ClinicalTrials.gov Identifier: NCT02737722    
Other Study ID Numbers: LAI2014-1
First Posted: April 14, 2016    Key Record Dates
Results First Posted: November 19, 2019
Last Update Posted: November 19, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Diabetic Foot
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetic Neuropathies