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NCT03732365

Phase 2 Randomized Study to Compare Ultrasonic Drug Delivery to Standard of Care for the Treatment of Infections in Non-Healing Wounds

Status unknown Phase 2 Last updated 6 November 2018
What this trial tests

Phase 2 trial testing Ultrasonic Drug Delivery in Acute Bacterial Skin and Skin Structure Infection (ABSSSI) in 30 participants. Status unknown.

Timeline
1 February 2019
Primary endpoint
31 January 2020
31 July 2020

Quick facts

Lead sponsorSonescence, Inc.
PhasePhase 2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment30
Start date1 February 2019
Primary completion31 January 2020
Estimated completion31 July 2020

Drugs / interventions tested

Conditions studied

Sponsor

Sonescence, Inc. — full company profile →

Who can join

Adults 18 to 80, any sex, with Acute Bacterial Skin and Skin Structure Infection (ABSSSI) or Non-healing Wound. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other Sonescence, Inc. trials

Trials by the same sponsor.

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