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Using bacteriophage therapy for diabetic foot infections

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

PHASE2 · Adaptive Phage Therapeutics, Inc. · NCT05177107

This study is testing if a new treatment using bacteriophages can help people with diabetic foot infections heal better and reduce their risk of infection after surgery.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment126 (estimated)
Ages18 Years to 85 Years
SexAll
SponsorAdaptive Phage Therapeutics, Inc. (industry)
Locations29 sites (Tucson, Arizona and 28 other locations)
Trial IDNCT05177107 on ClinicalTrials.gov

What this trial studies

This phase IIa trial aims to assess the safety and effectiveness of bacteriophage therapy in patients suffering from diabetic foot osteomyelitis caused by Staphylococcus aureus. Participants will be randomly assigned to receive either the phage therapy or a placebo following surgical debridement of their infected foot. The study will monitor the outcomes of the treatment in conjunction with standard care, including antibiotics. The goal is to determine if bacteriophage therapy can improve healing and reduce infection rates in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 85 with diabetes and a confirmed diagnosis of diabetic foot osteomyelitis requiring surgical intervention.

Not a fit: Patients whose ulcers have healed significantly prior to randomization or those receiving hyperbaric oxygen treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a novel treatment option for patients with difficult-to-treat diabetic foot infections.

How similar studies have performed: While bacteriophage therapy is a novel approach, preliminary studies have shown promise in treating bacterial infections, suggesting potential for success in this application.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Tucson, Arizona and 28 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Osteomyelitis, Diabetic Foot Osteomyelitis, Diabetes, Foot Infection, Phage Treatment, Bacteriophage, Phage, Bone Infection

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.