Bacteriophage Therapy in Patients With Diabetic Foot Osteomyelitis

Phase 2

Recruiting

• Conditions: Osteomyelitis; Diabetic Foot Osteomyelitis
• Interventions: Biological: Phage Therapy; Other: 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.

Study Timeline

• Study First Submitted: 2021-03-09
• Study Start: 2021-11-24
• Study First Submitted QC: 2021-12-15
• Study First Posted: 2022-01-04
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-05
• Last Update Posted: 2023-09-07
• Primary Completion: 2024-04
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 126

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.

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)

Compass Medical Research; 🇺🇸 Tucson, Arizona, United States

Southern Arizona VA Health Care System; 🇺🇸 Tucson, Arizona, United States

Central Arkansas Veteran's Healthcare System; 🇺🇸 Little Rock, Arkansas, United States

NorthBay Healthcare; 🇺🇸 Fairfield, California, United States

BioSolutions Clinical Research Center; 🇺🇸 La Mesa, California, United States

Harbor Hospital / UCLA; 🇺🇸 Torrance, California, United States

Rocky Mountain VA; 🇺🇸 Aurora, Colorado, United States

MedStar Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

South Lake Pain Institute; 🇺🇸 Clermont, Florida, United States

Midland Florida Clinical Research Center; 🇺🇸 DeLand, Florida, United States

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