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

NCT03732365 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-11-06

No results posted yet for this study

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.

Conditions

  • Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
  • Non-healing Wound

Interventions

COMBINATION_PRODUCT

Ultrasonic Drug Delivery

A maximum dose of 2 grams cefazolin in a solution of 1 gram/100 mL sterile saline will be injected into the affected area, followed by a 3-minute application of external ultrasound delivered at an acoustic intensity equal to 3 watts/square centimeter of surface area.

DRUG

Standard of Care Antibiotic Treatment

Antibiotic treatment according to the antibiotic package insert instructions for the particular gram-positive pathogen over a period of no more than 14 days.

Sponsors & Collaborators

  • University of Southern California

    collaborator OTHER

  • Sonescence, Inc.

    lead INDUSTRY

Principal Investigators

  • David G Armstrong, Ph.D., DPM · University of Southern California

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2020-01-31
Completion
2020-07-31
FDA Drug
Yes
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03732365 on ClinicalTrials.gov