drugset / Trial / NCT03732365
Phase 2 Randomized Study to Compare Ultrasonic Drug Delivery to Standard of Care for the Treatment of Infections in Non-Healing Wounds
RandomizedParallel-groupSingle-blindTreatment
Summary
This is a randomized study to compare the safety and efficacy of a single dose of up to 2 grams of cefazolin administered using a new drug delivery method called Ultrasonic Drug Delivery (UDD), combined with standard of care (SOC) antibiotic therapy, oral or IV, compared to standard of care (SOC) antibiotic therapy alone, in treating chronic wounds with skin and soft tissue infection, containing gram-positive pathogens, in lower extremities.
Timeline
- Start
- 2019-02-01
- Primary completion
- 2020-01-31
- Completion
- 2020-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cefazolin | Small molecule | 2 g | Other |