69
Participants
Start Date
January 31, 2022
Primary Completion Date
August 31, 2023
Study Completion Date
December 31, 2023
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.
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.
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.
Lead Sponsor
Precisio Biotix Therapeutics, Inc.
INDUSTRY