Phage Therapy for the Prevention and Treatment of Pressure Ulcers.
NCT ID: NCT04815798
Last Updated: 2021-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
69 participants
INTERVENTIONAL
2022-01-31
2023-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Bacteriophage-loaded Microcapsule Spray with Standard of Care
Phage therapy (Bacteriophage-loaded Microcapsule Spray) will be administered topically in conjunction with standard of care for pressure ulcers.
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.
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.
Placebo with Standard of Care
Placebo, analogous to the experimental arm, will be administered topically in conjunction with standard of care for pressure ulcers.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Stated willingness to comply with lifestyle considerations
4. Male or female, 18 years or older presenting in long-term care facilities, out-patient department or in-hospital patients with a stage II, III or IV pressure injury with or without local signs of infection with a size not exceeding 28 cm2
5. Within 72 hours before randomization, pressure injury specimen positive for S. aureus, P. aeruginosa, or K. pneumoniae determined by qPCR or rapid diagnostic test or conventional method or positive growth on specific agar.
6. For females of reproductive potential: use of a highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of administration of the study intervention
7. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner.
Exclusion Criteria
2. Pregnancy or lactation.
3. Known allergic reactions to components of SilvaSorb hydrogel.
4. Known allergic reactions to components of the phage treatment; including known allergic reactions to bacteriophages, polyester amide urea polymers and/or TMN buffer.
5. Unstable coronary artery disease.
6. Patients diagnosed with Type I or Type II diabetes, uncontrolled (HgbA1c \>8% or 2+ glycosuria).
7. Treatment with another investigational drug or other intervention within 30 days.
8. Intercurrent condition requiring a high dose of chronic corticosteroid therapy, immunosuppressive medication, oncologic chemotherapy.
9. Patients who have additional uncontrolled serious medical or psychiatric illness determined by the investigators where the patient is unfit to receive the product.
10. Chronic stool incontinence without a rectal tube if an individual has a sacral ulcer.
11. Placement of a wound vacuum.
12. Surgical wound closure planned within the study period.
13. Organ failure, acute respiratory failure and chronic renal failure.
14. Diagnosed osteomyelitis.
18 Years
ALL
No
Sponsors
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Precisio Biotix Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Gina Suh, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Karin Zachow, M.D.
Role: PRINCIPAL_INVESTIGATOR
Miami Veterans Affairs Healthcare System
Hector Bolivar, M.D.
Role: PRINCIPAL_INVESTIGATOR
Miami University Health System
Central Contacts
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Other Identifiers
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PGX-20001
Identifier Type: -
Identifier Source: org_study_id