Bacteriophage Therapy in Patients With Diabetic Foot Osteomyelitis

  • STATUS
    Recruiting
  • End date
    Oct 15, 2024
  • participants needed
    126
  • sponsor
    Adaptive Phage Therapeutics, Inc.
Updated on 7 October 2022
diabetes
debridement
diabetic foot

Summary

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

Description

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.

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

Eligibility

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

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.

Learn more

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

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note