TERMINATED

Bacteriophage Therapy in Patients With Diabetic Foot Osteomyelitis

Conditions

Osteomyelitis Diabetic Foot Osteomyelitis Diabetes Foot Infection Phage Treatment Bacteriophage Phage Bone Infection

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a phase 2b randomized trial designed to evaluate bacteriophage therapy in subjects with diabetic foot osteomyelitis.

Official Title

Phase 2b Randomized, Parallel, Double-blind, Placebo-Controlled, Repeat Dose, Multi-Site Study for Safety, Tolerability, and Efficacy of Personalized Phage Treatment and SoC for Subjects With Diabetic Foot Osteomyelitis Due to S. Aureus

Quick Facts

Study Start:2021-11-24

Study Completion:2025-05-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT05177107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Male or female ≥18 to \<85 years of age. * Ongoing diagnosis of diabetes. * Have undergone or are scheduled to undergo surgical debridement for DFO as part of SoC, with the associated bone culture positive for S. aureus * Availability of at least 1 matching phage for S. aureus cultured from the bone culture * Receiving SoC treatment for DFO, including antibiotics after debridement and before randomization * Meet defined study ulcer requirements as defined in the protocol * Adequate circulation to the affected extremity demonstrated within 3 months prior to randomization and no revascularization procedure anticipated * History of compliance with prior appointments and treatments in the investigator's opinion and willingness to receive and comply with SOC antimicrobial and clinical treatments for the study ulcer, including offloading	* Healing of the ulcer by more than 30% between screening and randomization. * Treated with hyperbaric oxygen or cellular/tissue products with 30 days of screening * Suspicion of neoplasm associated with the study ulcer or any non-study diabetic ulcer independent of biopsy result. * Presence of any cellulitis not localized to the study ulcer. * Indwelling hardware at the site of the DFO. * Body weight \<50 kg. * Presence of above ankle ulcer, with \>50% above medial malleolus * Hemoglobin \< 7g/dL * Abnormal liver function tests * History of underlying liver disease at screening or within last 3 months * Positive test for HIV-1 and /or HIV-2 * Any other clinically significant or severe disease that in the judgment of the investigator makes the patient unfit for the study or likely to withdraw prematurely from the study, or that could jeopardize the safety of the patient or confound the results of the study. * Known allergy to phage products. * Pregnant and/or breastfeeding. * Immunocompromised at screening in the judgment of the investigator. * Taking any systemic or topical antibacterial antibiotic within 2 weeks prior to the start of study treatment, for a condition other than Diabetic Foot Infection and DFO. * Taking any antiviral medication within 2 weeks prior to the start of study treatment and up through the last administration of study treatment. * Taking and/or receiving any therapies for the study ulcer that are not considered to be SOC. * More than 30 days has elapsed between screening and randomization (start of treatment) * Participating in another clinical trial within 4 weeks prior to screening. * Inability to obtain or provide informed consent or adhere to the protocol in the judgment of the investigator. * Once approximately 30% of subjects are enrolled with DFO involving digits, additional subjects will be excluded.

Inclusion Criteria

Exclusion Criteria

* Male or female ≥18 to \<85 years of age.
* Ongoing diagnosis of diabetes.
* Have undergone or are scheduled to undergo surgical debridement for DFO as part of SoC, with the associated bone culture positive for S. aureus
* Availability of at least 1 matching phage for S. aureus cultured from the bone culture
* Receiving SoC treatment for DFO, including antibiotics after debridement and before randomization
* Meet defined study ulcer requirements as defined in the protocol
* Adequate circulation to the affected extremity demonstrated within 3 months prior to randomization and no revascularization procedure anticipated
* History of compliance with prior appointments and treatments in the investigator's opinion and willingness to receive and comply with SOC antimicrobial and clinical treatments for the study ulcer, including offloading

* Healing of the ulcer by more than 30% between screening and randomization.
* Treated with hyperbaric oxygen or cellular/tissue products with 30 days of screening
* Suspicion of neoplasm associated with the study ulcer or any non-study diabetic ulcer independent of biopsy result.
* Presence of any cellulitis not localized to the study ulcer.
* Indwelling hardware at the site of the DFO.
* Body weight \<50 kg.
* Presence of above ankle ulcer, with \>50% above medial malleolus
* Hemoglobin \< 7g/dL
* Abnormal liver function tests
* History of underlying liver disease at screening or within last 3 months
* Positive test for HIV-1 and /or HIV-2
* Any other clinically significant or severe disease that in the judgment of the investigator makes the patient unfit for the study or likely to withdraw prematurely from the study, or that could jeopardize the safety of the patient or confound the results of the study.
* Known allergy to phage products.
* Pregnant and/or breastfeeding.
* Immunocompromised at screening in the judgment of the investigator.
* Taking any systemic or topical antibacterial antibiotic within 2 weeks prior to the start of study treatment, for a condition other than Diabetic Foot Infection and DFO.
* Taking any antiviral medication within 2 weeks prior to the start of study treatment and up through the last administration of study treatment.
* Taking and/or receiving any therapies for the study ulcer that are not considered to be SOC.
* More than 30 days has elapsed between screening and randomization (start of treatment)
* Participating in another clinical trial within 4 weeks prior to screening.
* Inability to obtain or provide informed consent or adhere to the protocol in the judgment of the investigator.
* Once approximately 30% of subjects are enrolled with DFO involving digits, additional subjects will be excluded.

Contacts and Locations

Principal Investigator

Nitsan Halevy, MD

PRINCIPAL_INVESTIGATOR

Medical Director

Study Locations (Sites)

Southern Arizona VA Health Care System

Tuscon, Arizona, 85723

United States

NorthBay Healthcare

Fairfield, California, 94534

United States

Harbor Hospital / UCLA

Torrance, California, 90502

United States

Rocky Mountain VA

Aurora, Colorado, 80045

United States

Holy Cross Health

Fort Lauderdale, Florida, 33308

United States

Infectious Disease Consultants od the Treasure Coast

Sebastian, Florida, 32958

United States

Podiatry 1st / Gateway Clinical Trials

O'Fallon, Illinois, 62269

United States

Foot & Ankle Center of Illinois

Springfield, Illinois, 62704

United States

Henry Ford Health

Detroit, Michigan, 48202

United States

Holy Name Medical Center

Teaneck, New Jersey, 07666

United States

CurAlta Foot and Ankle

Westwood, New Jersey, 07675

United States

Futuro Clinical Trials, LLC

McAllen, Texas, 78501

United States

Bio X Cell Research LLC

San Antonio, Texas, 78224

United States

Foot and Ankle Specialists of the Mid-Atlantic

Salem, Virginia, 24153

United States

Salem VA

Salem, Virginia, 24153

United States

Collaborators and Investigators

Sponsor: Adaptive Phage Therapeutics, Inc.

Nitsan Halevy, MD, PRINCIPAL_INVESTIGATOR, Medical Director

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-24

Study Completion Date2025-05-30

Study Record Updates

Study Start Date2021-11-24

Study Completion Date2025-05-30

Terms related to this study

Keywords Provided by Researchers

Diabetes
Osteomyelitis
Foot Infection
Phage Treatment
Bacteriophage
Phage
Bone Infection

Additional Relevant MeSH Terms

Osteomyelitis
Diabetic Foot Osteomyelitis