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Phage Therapy for the Prevention and Treatment of Pressure Ulcers.

NCT04815798 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2021-12-21

No results posted yet for this study

Summary

This study will evaluate a topical bacteriophage therapy product (BACTELIDE) as an adjunct to standard therapy for the prevention and treatment of pressure ulcers colonized with S. aureus, P. aeruginosa, or K. pneumoniae species.

This study will compare the safety and efficacy of BACTELIDE in conjunction with standard of care (SOC) versus a placebo in conjunction with standard of care.

Conditions

  • Pressure Ulcer

Interventions

COMBINATION_PRODUCT

Bacteriophage-loaded Microcapsule Spray

Study intervention consists of a dosage-metered airless spray containing a cocktail of 14 bacteriophages encapsulated in a biodegradable polymer. This bacteriophage product will be delivered topically every 3 days for 56 days or until wound has healed.

COMBINATION_PRODUCT

Placebo

Placebo intervention consists of a dosage-metered airless spray containing a buffer solution analogous to the study intervention. This placebo will be delivered topically every 3 days for 56 days or until wound has healed.

PROCEDURE

Standard of Care

Standard of care consists of but is not limited to offloading, positioning, cleansing, debridement, and wound dressing. A topical antimicrobial hydrogel will applied to wounds with signs of localized infection.

Sponsors & Collaborators

  • Precisio Biotix Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Gina Suh, M.D. · Mayo Clinic

  • Karin Zachow, M.D. · Miami Veterans Affairs Healthcare System

  • Hector Bolivar, M.D. · Miami University Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-31
Primary Completion
2023-08-31
Completion
2023-12-31
FDA Drug
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 NCT04815798 on ClinicalTrials.gov