Bacteriophage Therapy in Patients With Diabetic Foot Osteomyelitis
- Conditions
- OsteomyelitisDiabetic Foot Osteomyelitis
- Interventions
- Biological: Phage TherapyOther: Placebo
- Registration Number
- NCT05177107
- Lead Sponsor
- Adaptive Phage Therapeutics, Inc.
- Brief Summary
This is a phase IIa randomized trial designed to evaluate bacteriophage therapy in patients with diabetic foot osteomyelitis.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 126
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1: Phage Therapy Phage Therapy Bacteriophage therapy will be personalized for each patient dependent on phage susceptibility testing Group 2: Placebo Placebo Placebo (normal saline) will be administered using the same schedule and techniques as for Group 1 (phage therapy).
- Primary Outcome Measures
Name Time Method Percent area reduction of study ulcer through Week 13 Baseline through Week 13 Percent area reduction of the study ulcer surface area from baseline through Week 13
- Secondary Outcome Measures
Name Time Method Microbiological eradication of the target pathogen baseline through Week 13 Percentage of patients with microbiological eradication of the target pathogen at each time point during the study.
Complete healing of the study ulcer Baseline through Week 13 Time to complete healing of the ulcer at any time point during the study
Time to 85% reduction of C-reactive protein (CRP) Baseline through Week 13 Time to 85% reduction of CRP at any time point during the study
Trial Locations
- Locations (29)
Harbor Hospital / UCLA
🇺🇸Torrance, California, United States
Central Arkansas Veteran's Healthcare System
🇺🇸Little Rock, Arkansas, United States
MedStar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Infectious Disease Consultants od the Treasure Coast
🇺🇸Sebastian, Florida, United States
Futuro Clinical Trials, LLC
🇺🇸McAllen, Texas, United States
Bio X Cell Research LLC
🇺🇸San Antonio, Texas, United States
South Lake Pain Institute
🇺🇸Clermont, Florida, United States
Foot and Ankle Specialists of the Mid-Atlantic
🇺🇸Salem, Virginia, United States
Compass Medical Research
🇺🇸Tucson, Arizona, United States
Southern Arizona VA Health Care System
🇺🇸Tucson, Arizona, United States
Holy Cross Health
🇺🇸Fort Lauderdale, Florida, United States
Rocky Mountain VA
🇺🇸Aurora, Colorado, United States
NorthBay Healthcare
🇺🇸Fairfield, California, United States
BioSolutions Clinical Research Center
🇺🇸La Mesa, California, United States
Midland Florida Clinical Research Center
🇺🇸DeLand, Florida, United States
University of Florida Health - Jacksonville
🇺🇸Jacksonville, Florida, United States
LCC Medical Research
🇺🇸Miami, Florida, United States
Floridian Clinical Research
🇺🇸Miami Lakes, Florida, United States
Advanced Specialty Research
🇺🇸Boise, Idaho, United States
Foot & Ankle Center of Illinois
🇺🇸Springfield, Illinois, United States
Podiatry 1st / Gateway Clinical Trials
🇺🇸O'Fallon, Illinois, United States
CurAlta Foot and Ankle
🇺🇸Westwood, New Jersey, United States
Holy Name Medical Center
🇺🇸Teaneck, New Jersey, United States
Cardio Voyage / Texoma Health
🇺🇸Denison, Texas, United States
James J. Peters VA
🇺🇸Bronx, New York, United States
Nextstage Tulsa
🇺🇸Tulsa, Oklahoma, United States
Salem VA
🇺🇸Salem, Virginia, United States
Henry Ford Health
🇺🇸Detroit, Michigan, United States
Jersey Shore University Medical Center
🇺🇸Neptune, New Jersey, United States