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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00516958 | Pilot Study of the Safety and Clinical Efficacy of Topical Dermacyn™ Wound Care to Treat Mild Diabetic Foot Infections | PHASE2 | COMPLETED | 65 | — | — | May 1, 2007 | Dec 1, 2007 | Jan 14, 2008 | 16 | United States |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Topical Dermacyn |
| 2 | ACTIVE_COMPARATOR | Topical Dermacyn and levofloxacin |
| 3 | ACTIVE_COMPARATOR | Topical saline and levofloxacin |
| Name | Type | Description |
|---|---|---|
| Topical Dermacyn | DRUG | Topical Dermacyn once a day for 10 Days |
| Topical Dermacyn and Levofloxacin | DRUG | Topical Dermacyn once a day and levofloxacin 750 mg PO per day; both for 10 days |
| Topical Saline and Levofloxacin | DRUG | Topical saline once a day and levofloxacin 750 mg PO daily, both for 10 days |
Inclusion Criteria: * A patient must meet all of the following inclusion criteria to be enrolled in the study: 1. Males and females \> 18 years of age with diabetes mellitus (type 1 or type 2, controlled). 2. Presence of infected, non-ischemic diabetic foot ulcer that involves skin and deeper ...