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

NCT03732365

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

EvaluationDrugModalityDoseRoute
Subject Cefazolin Small molecule 2 g Other

Indications