| Outcome Measures: |
Primary: 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: Mean Change From Baseline in the Diabetic Ulcer Severity Score (DUSS), 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., Baseline and Day 15 (Visit 5)|Mean Change From Baseline in the Diabetic Foot Ulcer Wound Infection Score, 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)., Baseline; Day 15 (Visit 5)|Mean Change From Baseline in Ulcer Area in the ITT Population, 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., Baseline; Day 15 (Visit 5)|Mean Change From Baseline in the Percentage of Area Reduction for Ulcers in the ITT Population, 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., Baseline; Day 15 (Visit 5)|Mean Change From Baseline in Ulcer Area in the Per-Protocol Population, 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., Baseline; Day 15 (Visit 5)|Mean Change From Baseline in the Percentage of Area Reduction for Ulcers in the Per-Protocol Population, 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., Baseline; Day 15 (Visit 5)
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| Locations: |
Center for Clinical Research, Inc., San Francisco, California, 94115, United States|Journey Research, Inc., Oldsmar, Florida, 34677, United States|Clinical Research Solutions, Franklin, Tennessee, 37067, United States
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