Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02737722 | Topically Applied Bisphosphocin Nu-3 on Infected Diabetic Ulcers of Subjects With Type I or II Diabetes Mellitus | PHASE1 | COMPLETED | 31 | — | — | Apr 1, 2016 | Feb 1, 2018 | Nov 19, 2019 | 3 | United States |
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.
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.
| Arm | Type | Description |
|---|---|---|
| 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 |
| Placebo | PLACEBO_COMPARATOR | Dosage Form: Diluent, Frequency: QD for day 1, 2x daily for 7 days, Duration: 8 days |
| Name | Type | Description |
|---|---|---|
| Bisphosphocin Nu-3 | DRUG | - |
| Placebo | DRUG | - |
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investigation-related procedure not part of standard medical care, and with the understanding that consent may be withdrawn at any time without prejudice to fut...