- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04289948
Assessing the Efficacy of Anti-staphylococcal Phages in the Management of Infected Foot Ulcers in Diabetes (PDFI)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Work Package 1
WP1 is a safety cohort pilot study targeting patients with DFU which are non-infected as determined by the IDSA criteria. 20 participants will be recruited from Diabetic Foot Clinic at the Royal Derby Hospital. Phage gel will be applied to the index ulcer after the first and second sets of measures at baseline, weeks 1, 2 and 3. Samples will be taken at baseline and weekly up to 4 weeks by surface swab and deep tissue sample for determination of bacterial colonisation using both conventional and genotypic (molecular) microbiological methods, prior to any IMP application.
Work Package 2
WP2 is a pilot double blind, placebo-controlled, randomised study targeting patients with mild or moderate infection of DFUs and comparing systemic antibiotic therapy plus phage gel against systemic antibiotics therapy plus placebo gel. A total of 50 participants from two centres (foot clinics at Royal Derby Hospital and City Campus, Nottingham University Hospitals NHS Trust) will be recruited. Phage gel or placebo will be applied to the index ulcer after the first and second sets of measures at baseline, weeks 1, 2 and 3. Samples will be taken at baseline and weekly up to 4 weeks by surface swab and deep tissue sample for determination of bacterial colonisation using both conventional and genotypic (molecular) microbiological methods
Work Package 3
WP3 is an observer-blind RCT targeting patients with mild diabetic foot infection by IDSA criteria and comparing phage gel with systemic antibiotics. A total of 50 participants from two centres (foot clinics at Royal Derby Hospital and City Campus, Nottingham University Hospitals NHS Trust) will be recruited. Those with moderately severe infections will be withheld from this work package because of the clinical and ethical issues associated with withholding antibiotics in those with a moderately severe infection.
Study Type
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Derbyshire
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Derby, Derbyshire, United Kingdom, DE22 3DT
- University Hospitals Derby and Burton NHS Foundation Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diabetes Mellitus according to WHO criteria
- are aged 18 years or over
Additionally, patients must meet one of the following criteria to participate in the described Work Package:
- Patients are only eligible for WP1 if they also have one or more DFUs (area 25mm2) below the malleoli without infection according to IDSA criteria that have been present for at least 4 weeks
- Patients are only eligible for WP2 if they also have one or more DFUs (area 25mm2) below the malleoli with mild or moderate infection according to IDSA criteria that have been present for at least 4 weeks
- Patients are only eligible for WP3 if they also have one or more DFUs (area 25mm2) below the malleoli with mild infection according to IDSA criteria that have been present for at least 4 weeks
Exclusion Criteria:
We will exclude patients who meet ANY of the following criteria:
- with mental incapacity to give informed consent,
- who have other major co-morbidities, which in the opinion of the investigator would mean that the patient would not be able to complete the study
- with significant peripheral arterial disease (PAD): ABPI (ankle brachial pressure index) <0.7,
- Who have osteomyelitis defined by agreed clinical criteria
- who are receiving treatment with systemic glucocorticoids or other immunosuppressants,
- who have received systemic or topical antibiotics in the preceding 14 days,
- who are judged to require parenteral administration of antibiotics,
- Who have been previously recruited to an earlier part of the project
- who are women of childbearing age who are at risk of conception
- History of antibiotic hypersensitivity
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
The studies will be undertaken using a cocktail of at least 2-3 anti-staphylococcal phages produced by Intralytix Inc, Baltimore, Maryland, USA.
The phages will be included in a gel designed for application directly to the wound surface and packaged in 5 ml single use tubes.
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Experimental: Phage
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The studies will be undertaken using a cocktail of at least 2-3 anti-staphylococcal phages produced by Intralytix Inc, Baltimore, Maryland, USA.
The phages will be included in a gel designed for application directly to the wound surface and packaged in 5 ml single use tubes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Work Package 1: To assess the safety of the use of anti-staphylococcal phages therapy on the wound bacterial microbiome of uninfected DFU's.
Time Frame: 7 months
|
- Safety : Clinically significant change in safety bloods, vital signs, Full Blood Count (FBC), renal function, C-Reactive protein (CRP), Liver function Tests (LFT)s, Adverse events
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7 months
|
Work Package 2
Time Frame: 16 months
|
To compare the effect on the microbiome of empirical systemic antibiotic therapy alone (ESAT) versus ESAT plus phage therapy in ulcers complicated by mild or moderate infection as assessed by IDSA criteria
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16 months
|
Work Package 3
Time Frame: 16 months
|
To compare the use of empirical systemic antibiotic therapy versus phage therapy in ulcers complicated by mild infection on the eradication of the infection as assessed by IDSA criteria.
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16 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Work Package 1: Safety of phage gel and overt toxic effect of phage gel.
Time Frame: 7 months
|
The following outcomes will be recorded at weekly intervals for 4 weeks from baseline:
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7 months
|
Work Package 1: • Impact on the bacterial microbiome of anti-staphylococcal phage gel and systemically chosen antibiotics.
Time Frame: 7 months
|
The following outcomes will be recorded at weekly intervals for 4 weeks from baseline:
|
7 months
|
Work Package 2: Safety of phage gel and overt toxic effect of phage gel.
Time Frame: 7 months
|
The following outcomes will be recorded at weekly intervals for 4 weeks from baseline:
|
7 months
|
Work Package 2: Clinical benefit and patient well-being associated with adding phage gel to systemically chosen antibiotics compared to placebo in the management of mild or moderate infection.
Time Frame: 16 months
|
The following outcomes will be recorded at weekly intervals for 4 weeks from baseline:
|
16 months
|
Work Package 2: Impact on the bacterial microbiome of systemically chosen antibiotics and of anti-staphylococcal phage gel.
Time Frame: 16 months
|
The following outcomes will be recorded at weekly intervals for 4 weeks from baseline:
|
16 months
|
Work Package 3: Safety of phage gel and overt toxic effect of phage gel.
Time Frame: 16 months
|
The following outcomes will be recorded at weekly intervals for 4 weeks from baseline:
|
16 months
|
Work Package 3: Clinical benefit and patient well-being associated with phage gel therapy compared to systemically chosen antibiotics in the management of mild infection.
Time Frame: 16 months
|
The following outcomes will be recorded at weekly intervals for 4 weeks from baseline:
|
16 months
|
Work Package 3: Impact on the bacterial microbiome of systemically chosen antibiotics and of anti-staphylococcal phage gel.
Time Frame: 16 months
|
The following outcomes will be recorded at weekly intervals for 4 weeks from baseline:
|
16 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DHRD/2018/080
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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