Phage Therapy for the Prevention and Treatment of Pressure Ulcers.

PHASE1/PHASE2UnknownINTERVENTIONAL
Enrollment

69

Participants

Timeline

Start Date

January 31, 2022

Primary Completion Date

August 31, 2023

Study Completion Date

December 31, 2023

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.

All Listed Sponsors
lead

Precisio Biotix Therapeutics, Inc.

INDUSTRY

NCT04815798 - Phage Therapy for the Prevention and Treatment of Pressure Ulcers. | Biotech Hunter | Biotech Hunter