Bacteriophage Therapy in Patients With Diabetic Foot Osteomyelitis

NCT05177107 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: APT.DFI.001
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 15

Brief Summary

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

Conditions

Osteomyelitis; Diabetic Foot Osteomyelitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percent area reduction of study ulcer through Week 13

  Percent area reduction of the study ulcer surface area from baseline through Week 13

  Baseline through Week 13

Secondary Outcomes (3)

• Complete healing of the study ulcer

  Baseline through Week 13

• Time to 85% reduction of C-reactive protein (CRP)

  Baseline through Week 13

• Microbiological eradication of the target pathogen

  baseline through Week 13

Other Outcomes (1)

• Treatment-emergent AEs due to phage therapy

  baseline through Week 12

Study Arms (2)

Group 1: Phage Therapy

EXPERIMENTAL

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

Biological: Bacteriophage Therapy

Group 2: Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Bacteriophage Therapy BIOLOGICAL

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

Group 1: Phage Therapy

Placebo OTHER

Placebo (normal saline)

Group 2: Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Adaptive Phage Therapeutics, Inc.: lead

Study Sites (15)

Southern Arizona VA Health Care System

Tuscon, Arizona, 85723, United States

Location

NorthBay Healthcare

Fairfield, California, 94534, United States

Location

Harbor Hospital / UCLA

Torrance, California, 90502, United States

Location

Rocky Mountain VA

Aurora, Colorado, 80045, United States

Location

Holy Cross Health

Fort Lauderdale, Florida, 33308, United States

Location

Infectious Disease Consultants od the Treasure Coast

Sebastian, Florida, 32958, United States

Location

Podiatry 1st / Gateway Clinical Trials

O'Fallon, Illinois, 62269, United States

Location

Foot & Ankle Center of Illinois

Springfield, Illinois, 62704, United States

Location

Henry Ford Health

Detroit, Michigan, 48202, United States

Location

Holy Name Medical Center

Teaneck, New Jersey, 07666, United States

Location

CurAlta Foot and Ankle

Westwood, New Jersey, 07675, United States

Location

Futuro Clinical Trials, LLC

McAllen, Texas, 78501, United States

Location

Bio X Cell Research LLC

San Antonio, Texas, 78224, United States

Location

Foot and Ankle Specialists of the Mid-Atlantic

Salem, Virginia, 24153, United States

Location

Salem VA

Salem, Virginia, 24153, United States

Location

MeSH Terms

Conditions

Osteomyelitis; Diabetes Mellitus

Interventions

Phage Therapy

Condition Hierarchy (Ancestors)

Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Nitsan Halevy, MD

  Medical Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-blind: Patient will be randomized to receive either active phage or placebo treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2:1, phage: placebo

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: January 4, 2022
• Study Start: November 24, 2021
• Primary Completion: January 30, 2025
• Study Completion: May 30, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)