Bacteriophage Therapy in Patients With Diabetic Foot Osteomyelitis (DANCE)

August 14, 2025 updated by: Adaptive Phage Therapeutics, Inc.

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tuscon, Arizona, United States, 85723
        • Southern Arizona VA Health Care System
    • California
      • Fairfield, California, United States, 94534
        • NorthBay Healthcare
      • Torrance, California, United States, 90502
        • Harbor Hospital / UCLA
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Rocky Mountain VA
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Holy Cross Health
      • Sebastian, Florida, United States, 32958
        • Infectious Disease Consultants od the Treasure Coast
    • Illinois
      • O'Fallon, Illinois, United States, 62269
        • Podiatry 1st / Gateway Clinical Trials
      • Springfield, Illinois, United States, 62704
        • Foot & Ankle Center of Illinois
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health
    • New Jersey
      • Teaneck, New Jersey, United States, 07666
        • Holy Name Medical Center
      • Westwood, New Jersey, United States, 07675
        • Curalta Foot and Ankle
    • Texas
      • McAllen, Texas, United States, 78501
        • Futuro Clinical Trials, LLC
      • San Antonio, Texas, United States, 78224
        • Bio X Cell Research LLC
    • Virginia
      • Salem, Virginia, United States, 24153
        • Foot and Ankle Specialists of the Mid-Atlantic
      • Salem, Virginia, United States, 24153
        • Salem VA

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1: Phage Therapy
Bacteriophage therapy will be personalized for each patient dependent on phage susceptibility testing
Biological: Bacteriophage Therapy
Bacteriophage therapy will be personalized for each patient dependent on phage susceptibility testing
Placebo Comparator: Group 2: Placebo
Placebo (normal saline) will be administered using the same schedule and techniques as for Group 1 (phage therapy).
Other: Placebo
Placebo (normal saline)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent area reduction of study ulcer through Week 13
Time Frame: Baseline through Week 13
Percent area reduction of the study ulcer surface area from baseline through Week 13
Baseline through Week 13

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete healing of the study ulcer
Time Frame: Baseline through Week 13
Time to complete healing of the ulcer at any time point during the study
Baseline through Week 13
Time to 85% reduction of C-reactive protein (CRP)
Time Frame: Baseline through Week 13
Time to 85% reduction of CRP at any time point during the study
Baseline through Week 13
Microbiological eradication of the target pathogen
Time Frame: baseline through Week 13
Percentage of patients with microbiological eradication of the target pathogen at each time point during the study.
baseline through Week 13

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment-emergent AEs due to phage therapy
Time Frame: baseline through Week 12
Number and percent of treatment-emergent Adverse Events
baseline through Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adaptive Phage Therapeutics, Inc.

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: Nitsan Halevy, MD, Medical Director

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

November 24, 2021

Primary Completion (Actual)

January 30, 2025

Study Completion (Actual)

May 30, 2025

Study Registration Dates

First Submitted

March 9, 2021

First Submitted That Met QC Criteria

December 15, 2021

First Posted (Actual)

January 4, 2022

Study Record Updates

Last Update Posted (Actual)

August 19, 2025

Last Update Submitted That Met QC Criteria

August 14, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APT.DFI.001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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