Bacteriophage Therapy in Patients With Diabetic Foot Osteomyelitis

NCT ID: NCT05177107

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-24
• Study Completion Date: 2025-05-30

Brief Summary

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

Detailed Description

This study will evaluate the safety and efficacy of bacteriophage therapy in subjects with diabetic foot osteomyelitis (DFO). Enrolled subjects will have osteomyelitis infections due to Staph aureus. This study will include eligible subjects who have undergone or are planning to undergo surgical debridement of DFO.

Conditions

Osteomyelitis; Diabetic Foot Osteomyelitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group 1: Phage Therapy

Bacteriophage therapy will be personalized for each patient dependent on phage susceptibility testing

Group Type: EXPERIMENTAL

Bacteriophage Therapy

Intervention Type: BIOLOGICAL

Bacteriophage therapy will be personalized for each patient dependent on phage susceptibility testing

Group 2: Placebo

Placebo (normal saline) will be administered using the same schedule and techniques as for Group 1 (phage therapy).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo (normal saline)

Interventions

Bacteriophage Therapy

Bacteriophage therapy will be personalized for each patient dependent on phage susceptibility testing

Intervention Type: BIOLOGICAL

Placebo

Placebo (normal saline)

Intervention Type: OTHER

Eligibility Criteria

Inclusion 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Adaptive Phage Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nitsan Halevy, MD

Role: PRINCIPAL_INVESTIGATOR

Medical Director

Locations

Southern Arizona VA Health Care System

Tuscon, Arizona, United States

NorthBay Healthcare

Fairfield, California, United States

Harbor Hospital / UCLA

Torrance, California, United States

Rocky Mountain VA

Aurora, Colorado, United States

Holy Cross Health

Fort Lauderdale, Florida, United States

Infectious Disease Consultants od the Treasure Coast

Sebastian, Florida, United States

Podiatry 1st / Gateway Clinical Trials

O'Fallon, Illinois, United States

Foot & Ankle Center of Illinois

Springfield, Illinois, United States

Henry Ford Health

Detroit, Michigan, United States

Holy Name Medical Center

Teaneck, New Jersey, United States

CurAlta Foot and Ankle

Westwood, New Jersey, United States

Futuro Clinical Trials, LLC

McAllen, Texas, United States

Bio X Cell Research LLC

San Antonio, Texas, United States

Foot and Ankle Specialists of the Mid-Atlantic

Salem, Virginia, United States

Salem VA

Salem, Virginia, United States

Countries

United States

Other Identifiers

APT.DFI.001

Identifier Type: -

Identifier Source: org_study_id