Status:
WITHDRAWN
Assessing the Efficacy of Anti-staphylococcal Phages in the Management of Infected Foot Ulcers in Diabetes
Lead Sponsor:
University Hospitals of Derby and Burton NHS Foundation Trust
Collaborating Sponsors:
Wellcome Trust
BioPhage Theraputics Limited
Conditions:
Diabetes
Diabetic Foot
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Work Package 1: Observational cohort pilot safety study Work Package 2: Randomised, double-blind, placebo controlled pilot study Work Package 3: Observer-blind pilot RCT
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04289948
Start Date
March 1 2019
End Date
September 1 2022
Last Update
February 28 2020
Active Locations (1)
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1
University Hospitals Derby and Burton NHS Foundation Trust
Derby, Derbyshire, United Kingdom, DE22 3DT