A Phase 2 interventional study of Bacteriophage Therapy and Placebo in Osteomyelitis and Diabetic Foot Osteomyelitis, sponsored by Adaptive Phage Therapeutics, Inc.. Terminated at 15 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-08-19.
Sponsored by Adaptive Phage Therapeutics, Inc. · Phase 2, Interventional, and Treatment
This is a phase 2b randomized trial designed to evaluate bacteriophage therapy in subjects with diabetic foot osteomyelitis.
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.
105 studies on the registry are indexed under Osteomyelitis; 30 are open to participants now.
This study's enrollment of 41 is below the median of 74 across 60 interventional studies indexed under Osteomyelitis.
Browse Osteomyelitis studies →Adaptive Phage Therapeutics, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bacteriophage therapy will be personalized for each patient dependent on phage susceptibility testing
Biological: Bacteriophage Therapy
Placebo (normal saline) will be administered using the same schedule and techniques as for Group 1 (phage therapy).
Other: Placebo
Bacteriophage therapy will be personalized for each patient dependent on phage susceptibility testing
Placebo (normal saline)
Percent area reduction of study ulcer through Week 13
Percent area reduction of the study ulcer surface area from baseline through Week 13
Time frame: Baseline through Week 13
Complete healing of the study ulcer
Time to complete healing of the ulcer at any time point during the study
Time frame: Baseline through Week 13
Time to 85% reduction of C-reactive protein (CRP)
Time to 85% reduction of CRP at any time point during the study
Time frame: Baseline through Week 13
Microbiological eradication of the target pathogen
Percentage of patients with microbiological eradication of the target pathogen at each time point during the study.
Time frame: baseline through Week 13
Treatment-emergent AEs due to phage therapy
Number and percent of treatment-emergent Adverse Events
Time frame: baseline through Week 12
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2021 to primary completion in Jan 2025, 38 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Adaptive Phage Therapeutics, Inc.