Trial Outcomes & Findings for Topically Applied Bisphosphocin Nu-3 on Infected Diabetic Ulcers of Subjects With Type I or II Diabetes Mellitus (NCT NCT02737722)
NCT ID: NCT02737722
Last Updated: 2019-11-19
Results Overview
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.
COMPLETED
PHASE1/PHASE2
31 participants
up to Day 15 (Visit 5)
2019-11-19
Participant Flow
Overall, 48 participants were screened; 17 were screen failures and weren't enrolled. One participant was enrolled but not randomized.
Participant milestones
| Measure |
0.1% Bisphosphocin Nu-3
Participants received a single topical administration of 0.1% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
|
1% Bisphosphocin Nu-3
Participants received a single topical administration of 1% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
|
2% Bisphosphocin Nu-3
Participants received a single topical administration of 2% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
|
Placebo
Participants received a single topical administration of matching placebo on Day 1. Participants then applied the same dose twice a day for 7 days.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
6
|
|
Overall Study
COMPLETED
|
8
|
8
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
0.1% Bisphosphocin Nu-3
Participants received a single topical administration of 0.1% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
|
1% Bisphosphocin Nu-3
Participants received a single topical administration of 1% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
|
2% Bisphosphocin Nu-3
Participants received a single topical administration of 2% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
|
Placebo
Participants received a single topical administration of matching placebo on Day 1. Participants then applied the same dose twice a day for 7 days.
|
|---|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Data were collected in the Per-Protocol Population, comprised of all participants who met enrollment criteria, received all doses of investigational product as required by the protocol, and had no major protocol violations.
Baseline characteristics by cohort
| Measure |
0.1% Bisphosphocin Nu-3
n=8 Participants
Participants received a single topical administration of 0.1% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
|
1% Bisphosphocin Nu-3
n=8 Participants
Participants received a single topical administration of 1% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
|
2% Bisphosphocin Nu-3
n=8 Participants
Participants received a single topical administration of 2% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
|
Placebo
n=6 Participants
Participants received a single topical administration of matching placebo on Day 1. Participants then applied the same dose twice a day for 7 days.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
55.6 years
STANDARD_DEVIATION 8.21 • n=8 Participants
|
59.3 years
STANDARD_DEVIATION 8.41 • n=8 Participants
|
60.5 years
STANDARD_DEVIATION 14.03 • n=8 Participants
|
61.0 years
STANDARD_DEVIATION 6.54 • n=6 Participants
|
59.0 years
STANDARD_DEVIATION 9.64 • n=30 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
6 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=6 Participants
|
24 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
White
|
0 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
3 Participants
n=6 Participants
|
17 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Unknown or Missing
|
8 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=6 Participants
|
11 Participants
n=30 Participants
|
|
Mean Diabetic Ulcer Wound Scoring System (DUSS) Score
|
1.13 units on a scale
STANDARD_DEVIATION 0.35 • n=8 Participants
|
1.25 units on a scale
STANDARD_DEVIATION 0.71 • n=8 Participants
|
1.13 units on a scale
STANDARD_DEVIATION 0.64 • n=8 Participants
|
1.00 units on a scale
STANDARD_DEVIATION 0.89 • n=6 Participants
|
1.13 units on a scale
STANDARD_DEVIATION 0.63 • n=30 Participants
|
|
Mean Diabetic Foot Ulcer Wound Infection Score
|
4.38 units on a scale
STANDARD_DEVIATION 0.92 • n=8 Participants
|
4.50 units on a scale
STANDARD_DEVIATION 1.60 • n=8 Participants
|
4.63 units on a scale
STANDARD_DEVIATION 1.69 • n=8 Participants
|
4.33 units on a scale
STANDARD_DEVIATION 1.31 • n=6 Participants
|
4.47 units on a scale
STANDARD_DEVIATION 1.31 • n=30 Participants
|
|
Mean Ulcer Area in the Intent-to-Treat Population
|
1.5 centimeters squared (cm^2)
STANDARD_DEVIATION 1.23 • n=8 Participants
|
1.8 centimeters squared (cm^2)
STANDARD_DEVIATION 1.54 • n=8 Participants
|
1.9 centimeters squared (cm^2)
STANDARD_DEVIATION 1.25 • n=8 Participants
|
0.8 centimeters squared (cm^2)
STANDARD_DEVIATION 0.20 • n=6 Participants
|
1.5 centimeters squared (cm^2)
STANDARD_DEVIATION 1.22 • n=30 Participants
|
|
Mean Ulcer Area in the Per-Protocol Population
|
1.7 cm^2
STANDARD_DEVIATION 1.36 • n=5 Participants • Data were collected in the Per-Protocol Population, comprised of all participants who met enrollment criteria, received all doses of investigational product as required by the protocol, and had no major protocol violations.
|
1.8 cm^2
STANDARD_DEVIATION 1.54 • n=8 Participants • Data were collected in the Per-Protocol Population, comprised of all participants who met enrollment criteria, received all doses of investigational product as required by the protocol, and had no major protocol violations.
|
1.9 cm^2
STANDARD_DEVIATION 1.25 • n=8 Participants • Data were collected in the Per-Protocol Population, comprised of all participants who met enrollment criteria, received all doses of investigational product as required by the protocol, and had no major protocol violations.
|
0.8 cm^2
STANDARD_DEVIATION 0.20 • n=6 Participants • Data were collected in the Per-Protocol Population, comprised of all participants who met enrollment criteria, received all doses of investigational product as required by the protocol, and had no major protocol violations.
|
1.6 cm^2
STANDARD_DEVIATION 1.24 • n=27 Participants • Data were collected in the Per-Protocol Population, comprised of all participants who met enrollment criteria, received all doses of investigational product as required by the protocol, and had no major protocol violations.
|
PRIMARY outcome
Timeframe: up to Day 15 (Visit 5)Population: Safety Population: all participants administered any amount of investigational product
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.
Outcome measures
| Measure |
0.1% Bisphosphocin Nu-3
n=8 Participants
Participants received a single topical administration of 0.1% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
|
1% Bisphosphocin Nu-3
n=8 Participants
Participants received a single topical administration of 1% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
|
2% Bisphosphocin Nu-3
n=8 Participants
Participants received a single topical administration of 2% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
|
Placebo
n=6 Participants
Participants received a single topical administration of matching placebo on Day 1. Participants then applied the same dose twice a day for 7 days.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-related Treatment-emergent Adverse Events as Graded According to the Common Terminology Criteria for Adverse Events v4.02 (CTCAE)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Days 1, 2, 9, and 15 (Visits 2, 3, 4, and 5, respectively)Population: Intent-to-Treat (ITT) Population: all randomized participants. Only those participants with available data were analyzed. Microbiology results were not collected in the database for participants in the 0.1% cohort.
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.
Outcome measures
| Measure |
0.1% Bisphosphocin Nu-3
Participants received a single topical administration of 0.1% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
|
1% Bisphosphocin Nu-3
n=8 Participants
Participants received a single topical administration of 1% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
|
2% Bisphosphocin Nu-3
n=8 Participants
Participants received a single topical administration of 2% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
|
Placebo
n=6 Participants
Participants received a single topical administration of matching placebo on Day 1. Participants then applied the same dose twice a day for 7 days.
|
|---|---|---|---|---|
|
Number of Participants With Normal and Abnormal Cultures at Visits 2, 3, 4, and 5
Day 9 (Visit 4), Normal Culture
|
—
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Normal and Abnormal Cultures at Visits 2, 3, 4, and 5
Day 1 (Visit 2), Normal Culture
|
—
|
2 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Normal and Abnormal Cultures at Visits 2, 3, 4, and 5
Day 1 (Visit 2), Abnormal Culture
|
—
|
6 participants
|
7 participants
|
4 participants
|
|
Number of Participants With Normal and Abnormal Cultures at Visits 2, 3, 4, and 5
Day 2 (Visit 3), Normal Culture
|
—
|
1 participants
|
2 participants
|
1 participants
|
|
Number of Participants With Normal and Abnormal Cultures at Visits 2, 3, 4, and 5
Day 2 (Visit 3), Abnormal Culture
|
—
|
7 participants
|
6 participants
|
3 participants
|
|
Number of Participants With Normal and Abnormal Cultures at Visits 2, 3, 4, and 5
Day 9 (Visit 4), Abnormal Culture
|
—
|
7 participants
|
7 participants
|
2 participants
|
|
Number of Participants With Normal and Abnormal Cultures at Visits 2, 3, 4, and 5
Day 15 (Visit 5), Normal Culture
|
—
|
1 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Normal and Abnormal Cultures at Visits 2, 3, 4, and 5
Day 15 (Visit 5), Abnormal Culture
|
—
|
6 participants
|
7 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline and Day 15 (Visit 5)Population: ITT Population. Only those participants with available data were analyzed.
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.
Outcome measures
| Measure |
0.1% Bisphosphocin Nu-3
n=8 Participants
Participants received a single topical administration of 0.1% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
|
1% Bisphosphocin Nu-3
n=8 Participants
Participants received a single topical administration of 1% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
|
2% Bisphosphocin Nu-3
n=7 Participants
Participants received a single topical administration of 2% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
|
Placebo
n=6 Participants
Participants received a single topical administration of matching placebo on Day 1. Participants then applied the same dose twice a day for 7 days.
|
|---|---|---|---|---|
|
Mean Change From Baseline in the Diabetic Ulcer Severity Score (DUSS)
|
0.13 score on a scale
Standard Deviation 0.64
|
-0.13 score on a scale
Standard Deviation 0.35
|
-0.14 score on a scale
Standard Deviation 0.69
|
-0.33 score on a scale
Standard Deviation 0.52
|
SECONDARY outcome
Timeframe: Baseline; Day 15 (Visit 5)Population: ITT Population. Only those participants with available data were analyzed.
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).
Outcome measures
| Measure |
0.1% Bisphosphocin Nu-3
n=8 Participants
Participants received a single topical administration of 0.1% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
|
1% Bisphosphocin Nu-3
n=8 Participants
Participants received a single topical administration of 1% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
|
2% Bisphosphocin Nu-3
n=7 Participants
Participants received a single topical administration of 2% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
|
Placebo
n=6 Participants
Participants received a single topical administration of matching placebo on Day 1. Participants then applied the same dose twice a day for 7 days.
|
|---|---|---|---|---|
|
Mean Change From Baseline in the Diabetic Foot Ulcer Wound Infection Score
|
-2.38 score on a scale
Standard Deviation 1.41
|
-1.50 score on a scale
Standard Deviation 3.42
|
-2.86 score on a scale
Standard Deviation 1.57
|
-3.00 score on a scale
Standard Deviation 2.10
|
SECONDARY outcome
Timeframe: Baseline; Day 15 (Visit 5)Population: ITT Population. Only those participants with available data were analyzed.
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.
Outcome measures
| Measure |
0.1% Bisphosphocin Nu-3
n=8 Participants
Participants received a single topical administration of 0.1% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
|
1% Bisphosphocin Nu-3
n=8 Participants
Participants received a single topical administration of 1% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
|
2% Bisphosphocin Nu-3
n=7 Participants
Participants received a single topical administration of 2% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
|
Placebo
n=6 Participants
Participants received a single topical administration of matching placebo on Day 1. Participants then applied the same dose twice a day for 7 days.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Ulcer Area in the ITT Population
|
-0.3 centimeters squared (cm^2)
Standard Deviation 0.62
|
-0.2 centimeters squared (cm^2)
Standard Deviation 0.77
|
-0.7 centimeters squared (cm^2)
Standard Deviation 0.68
|
-0.3 centimeters squared (cm^2)
Standard Deviation 0.32
|
SECONDARY outcome
Timeframe: Baseline; Day 15 (Visit 5)Population: ITT Population. Only those participants with available data were analyzed.
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.
Outcome measures
| Measure |
0.1% Bisphosphocin Nu-3
n=8 Participants
Participants received a single topical administration of 0.1% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
|
1% Bisphosphocin Nu-3
n=8 Participants
Participants received a single topical administration of 1% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
|
2% Bisphosphocin Nu-3
n=7 Participants
Participants received a single topical administration of 2% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
|
Placebo
n=5 Participants
Participants received a single topical administration of matching placebo on Day 1. Participants then applied the same dose twice a day for 7 days.
|
|---|---|---|---|---|
|
Mean Change From Baseline in the Percentage of Area Reduction for Ulcers in the ITT Population
|
25.2 percentage of area
Standard Deviation 34.41
|
10.8 percentage of area
Standard Deviation 51.94
|
54.0 percentage of area
Standard Deviation 36.67
|
41.0 percentage of area
Standard Deviation 41.56
|
SECONDARY outcome
Timeframe: Baseline; Day 15 (Visit 5)Population: Per-Protocol Population: all participants who met enrollment criteria, received all doses of investigational product as required by the protocol, and had no major protocol violations. Only those participants with available data were analyzed.
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.
Outcome measures
| Measure |
0.1% Bisphosphocin Nu-3
n=5 Participants
Participants received a single topical administration of 0.1% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
|
1% Bisphosphocin Nu-3
n=8 Participants
Participants received a single topical administration of 1% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
|
2% Bisphosphocin Nu-3
n=7 Participants
Participants received a single topical administration of 2% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
|
Placebo
n=6 Participants
Participants received a single topical administration of matching placebo on Day 1. Participants then applied the same dose twice a day for 7 days.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Ulcer Area in the Per-Protocol Population
|
-0.1 centimeters squared (cm^2)
Standard Deviation 0.37
|
-0.2 centimeters squared (cm^2)
Standard Deviation 0.77
|
-0.7 centimeters squared (cm^2)
Standard Deviation 0.68
|
-0.3 centimeters squared (cm^2)
Standard Deviation 0.32
|
SECONDARY outcome
Timeframe: Baseline; Day 15 (Visit 5)Population: Per-Protocol Population. Only those participants with available data were analyzed.
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.
Outcome measures
| Measure |
0.1% Bisphosphocin Nu-3
n=5 Participants
Participants received a single topical administration of 0.1% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
|
1% Bisphosphocin Nu-3
n=8 Participants
Participants received a single topical administration of 1% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
|
2% Bisphosphocin Nu-3
n=7 Participants
Participants received a single topical administration of 2% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
|
Placebo
n=5 Participants
Participants received a single topical administration of matching placebo on Day 1. Participants then applied the same dose twice a day for 7 days.
|
|---|---|---|---|---|
|
Mean Change From Baseline in the Percentage of Area Reduction for Ulcers in the Per-Protocol Population
|
22.4 percentage of area
Standard Deviation 39.77
|
10.8 percentage of area
Standard Deviation 51.94
|
54.0 percentage of area
Standard Deviation 36.67
|
41.0 percentage of area
Standard Deviation 41.56
|
POST_HOC outcome
Timeframe: Baseline; Day 15 (Visit 5)Population: Per-Protocol Population. Microbiology results were not collected in the database for participants in the 0.1% cohort.
Global impression of microbiological response was conducted by comparing culture value from Baseline to Visit 5 (Day 15). If culture values were not reported by the local laboratory, numerical values were assigned using the following criteria: heavy growth, 4+, moderate growth, 2+, scant, 1+, no bacteria, 0.
Outcome measures
| Measure |
0.1% Bisphosphocin Nu-3
Participants received a single topical administration of 0.1% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
|
1% Bisphosphocin Nu-3
n=8 Participants
Participants received a single topical administration of 1% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
|
2% Bisphosphocin Nu-3
n=8 Participants
Participants received a single topical administration of 2% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
|
Placebo
n=6 Participants
Participants received a single topical administration of matching placebo on Day 1. Participants then applied the same dose twice a day for 7 days.
|
|---|---|---|---|---|
|
Percentage of Participants With a Positive and Negative Global Clinical Impression of Microbiology Response
No apparent effect (negative)
|
—
|
62 percentage of participants
|
38 percentage of participants
|
75 percentage of participants
|
|
Percentage of Participants With a Positive and Negative Global Clinical Impression of Microbiology Response
Apparent effect (positive)
|
—
|
38 percentage of participants
|
62 percentage of participants
|
25 percentage of participants
|
POST_HOC outcome
Timeframe: Baseline; Day 15 (Visit 5)Population: Per-Protocol Population. Only those participants with available data were analyzed.
Percent change from Baseline is calculated as the \[(post-Baseline value minus the Baseline value)/Baseline value\] x 100. 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.
Outcome measures
| Measure |
0.1% Bisphosphocin Nu-3
n=5 Participants
Participants received a single topical administration of 0.1% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
|
1% Bisphosphocin Nu-3
n=8 Participants
Participants received a single topical administration of 1% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
|
2% Bisphosphocin Nu-3
n=7 Participants
Participants received a single topical administration of 2% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
|
Placebo
n=5 Participants
Participants received a single topical administration of matching placebo on Day 1. Participants then applied the same dose twice a day for 7 days.
|
|---|---|---|---|---|
|
Median Percent Change From Baseline in the Percentage Area Reduction for Ulcers in the Per-Protocol Population
|
4.6 percent change
Interval -13.5 to 87.9
|
13.1 percent change
Interval -77.2 to 89.2
|
65.6 percent change
Interval -4.0 to 90.1
|
29.9 percent change
Interval -10.8 to 84.5
|
Adverse Events
0.1% Bisphosphocin Nu-3
1% Bisphosphocin Nu-3
2% Bisphosphocin Nu-3
Placebo
Serious adverse events
| Measure |
0.1% Bisphosphocin Nu-3
n=8 participants at risk
Participants received a single topical administration of 0.1% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
|
1% Bisphosphocin Nu-3
n=8 participants at risk
Participants received a single topical administration of 1% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
|
2% Bisphosphocin Nu-3
n=8 participants at risk
Participants received a single topical administration of 2% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
|
Placebo
n=6 participants at risk
Participants received a single topical administration of matching placebo on Day 1. Participants then applied the same dose twice a day for 7 days.
|
|---|---|---|---|---|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/8 • up to Day 15 (Visit 5)
Treatment-emergent adverse events, defined as adverse events with onset times after dosing, or pre-existing adverse events that worsened during the study, are reported.
|
0.00%
0/8 • up to Day 15 (Visit 5)
Treatment-emergent adverse events, defined as adverse events with onset times after dosing, or pre-existing adverse events that worsened during the study, are reported.
|
12.5%
1/8 • up to Day 15 (Visit 5)
Treatment-emergent adverse events, defined as adverse events with onset times after dosing, or pre-existing adverse events that worsened during the study, are reported.
|
0.00%
0/6 • up to Day 15 (Visit 5)
Treatment-emergent adverse events, defined as adverse events with onset times after dosing, or pre-existing adverse events that worsened during the study, are reported.
|
Other adverse events
| Measure |
0.1% Bisphosphocin Nu-3
n=8 participants at risk
Participants received a single topical administration of 0.1% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
|
1% Bisphosphocin Nu-3
n=8 participants at risk
Participants received a single topical administration of 1% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
|
2% Bisphosphocin Nu-3
n=8 participants at risk
Participants received a single topical administration of 2% Nu-3 solution in saline on Day 1. Participants then applied the same dose twice a day for 7 days.
|
Placebo
n=6 participants at risk
Participants received a single topical administration of matching placebo on Day 1. Participants then applied the same dose twice a day for 7 days.
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/8 • up to Day 15 (Visit 5)
Treatment-emergent adverse events, defined as adverse events with onset times after dosing, or pre-existing adverse events that worsened during the study, are reported.
|
0.00%
0/8 • up to Day 15 (Visit 5)
Treatment-emergent adverse events, defined as adverse events with onset times after dosing, or pre-existing adverse events that worsened during the study, are reported.
|
12.5%
1/8 • up to Day 15 (Visit 5)
Treatment-emergent adverse events, defined as adverse events with onset times after dosing, or pre-existing adverse events that worsened during the study, are reported.
|
0.00%
0/6 • up to Day 15 (Visit 5)
Treatment-emergent adverse events, defined as adverse events with onset times after dosing, or pre-existing adverse events that worsened during the study, are reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place