OsteomyelitisPhase 2DANCENCT05177107
Bacteriophage Therapy in Patients With Diabetic Foot Osteomyelitis
A Phase 2 study testing Bacteriophage Therapy in people with Osteomyelitis and Diabetic Foot Osteomyelitis, run by Adaptive Phage Therapeutics, Inc. at 15 sites in United States.
Trial summary
This is a phase 2b randomized trial designed to evaluate bacteriophage therapy in subjects with diabetic foot osteomyelitis. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Osteomyelitis, Diabetic Foot Osteomyelitis
- What is being tested?
- Bacteriophage Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 15 sitesUnited States
- Study dates
- 24 Nov 2021to 30 May 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 22Show fewer
- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Rocky Mountain VA
Aurora, Colorado, 80045
Henry Ford Health
Detroit, Michigan, 48202
NorthBay Healthcare
Fairfield, California, 94534
Holy Cross Health
Fort Lauderdale, Florida, 33308
Futuro Clinical Trials, LLC
McAllen, Texas, 78501
Podiatry 1st / Gateway Clinical Trials
O'Fallon, Illinois, 62269
Foot and Ankle Specialists of the Mid-Atlantic
Salem, Virginia, 24153
Salem VA
Salem, Virginia, 24153
Bio X Cell Research LLC
San Antonio, Texas, 78224
Infectious Disease Consultants od the Treasure Coast
Sebastian, Florida, 32958
Foot & Ankle Center of Illinois
Springfield, Illinois, 62704
Holy Name Medical Center
Teaneck, New Jersey, 07666
Harbor Hospital / UCLA
Torrance, California, 90502
Southern Arizona VA Health Care System
Tuscon, Arizona, 85723
CurAlta Foot and Ankle
Westwood, New Jersey, 07675
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteomyelitis, Diabetic Foot Osteomyelitis
- Being tested
- Bacteriophage Therapy, Placebo
- Keywords
- Diabetes, Osteomyelitis, Foot Infection, Phage Treatment, Bacteriophage, Phage, Bone Infection
- Medical subject headings
- Osteomyelitis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacteriophage TherapyBiological
Bacteriophage therapy will be personalized for each patient dependent on phage susceptibility testing
PlaceboOther
Placebo (normal saline)
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Phage Therapy | Experimental | Bacteriophage therapy will be personalized for each patient dependent on phage susceptibility testing Receives: 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). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent area reduction of study ulcer through Week 13
Percent area reduction of the study ulcer surface area from baseline through Week 13
Measured: Baseline through Week 13
Secondary outcomes (3)
Complete healing of the study ulcer
Time to complete healing of the ulcer at any time point during the study
Measured: 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
Measured: 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.
Measured: baseline through Week 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start24 Nov 2021
- Primary completion30 Jan 2025
- Study completion30 May 2025
Why it stopped: Study reached minimum enrollment threshold
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteomyelitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2:1, phage: placebo
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adaptive Phage Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nitsan Halevy, MD, Principal investigator, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05177107
- Sponsor's protocol ID
- APT.DFI.001
- Acronym
- DANCE
- Status last verified
- Jan 2025
- First submitted
- 9 Mar 2021
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05177107
- Acronym / sponsor ID
- DANCE / APT.DFI.001
- Conditions
- Osteomyelitis, Diabetic Foot Osteomyelitis
- Keywords
- Diabetes, Osteomyelitis, Foot Infection, Phage Treatment, Bacteriophage, Phage, Bone Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study reached minimum enrollment threshold
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Adaptive Phage Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Nov 2021 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 4 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 2b randomized trial designed to evaluate bacteriophage therapy in subjects with diabetic foot osteomyelitis.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 2:1, phage: placebo
| Arm | Type | Receives |
|---|---|---|
| Group 1: Phage Therapy | Experimental | Biological: Bacteriophage TherapyBacteriophage therapy will be personalized for each patient dependent on phage susceptibility testing |
| Group 2: Placebo | Placebo comparator | Other: PlaceboPlacebo (normal saline) will be administered using the same schedule and techniques as for Group 1 (phage therapy). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bacteriophage TherapyBacteriophage therapy will be personalized for each patient dependent on phage susceptibility testing | Biological | Group 1: Phage Therapy |
| PlaceboPlacebo (normal saline) | Other | Group 2: Placebo |
Primary outcome
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
3 secondary outcomes
Complete healing of the study ulcer
Time frame: Baseline through Week 13
Time to 85% reduction of C-reactive protein (CRP)
Time frame: Baseline through Week 13
Microbiological eradication of the target pathogen
Time frame: baseline through Week 13
Results and safety
The study was stopped early (reason given: Study reached minimum enrollment threshold). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nitsan Halevy, MD principal investigator
Medical Director
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bacteriophage Therapy in people with Osteomyelitis and Diabetic Foot Osteomyelitis, run by Adaptive Phage Therapeutics, Inc. at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study reached minimum enrollment threshold). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent area reduction of study ulcer through Week 13 (time frame: Baseline through Week 13). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.