Bacteriophage Therapy in Patients With Diabetic Foot Osteomyelitis

  • End date
    Oct 15, 2024
  • participants needed
  • sponsor
    Adaptive Phage Therapeutics, Inc.
Updated on 7 October 2022
diabetic foot


This is a phase IIa randomized trial designed to evaluate bacteriophage therapy in patients with diabetic foot osteomyelitis.


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

Condition Osteomyelitis, Diabetic Foot Osteomyelitis
Treatment Placebo, Phage Therapy, Phage Therapy
Clinical Study IdentifierNCT05177107
SponsorAdaptive Phage Therapeutics, Inc.
Last Modified on7 October 2022


Yes No Not Sure

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 Standard of Care, with the associated bone culture positive for S. aureus and with the associated histology results consistent with the diagnosis of DFO
Meet defined study ulcer requirements as defined in the protocol

Exclusion Criteria

Healing of the ulcer by more than 30% between screening and randomization
Evidence of sinus tract
Suspicion of neoplasm associated with the study ulcer or any non-study diabetic ulcer independent of biopsy result
Presence of erythema ≥4 cm at the study ulcer site
Presence of any cellulitis not localized to the study ulcer
Indwelling hardware at the site of the DFO
Body mass index of >40 or weight <50 kg
Presence of leg ulcer(s), regardless of limb
Abnormal liver function tests
HbA1c value of more than 12%
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
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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