Assessing the Efficacy of Anti-staphylococcal Phages in the Management of Infected Foot Ulcers in Diabetes

• Status: Withdrawn
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospitals of Derby and Burton NHS Foundation Trust
• Collaborators: BioPhage Theraputics Limited; Nottingham University Hospitals NHS Trust; Wellcome Trust

Criteria

Inclusion Criteria:

1. Diabetes Mellitus according to WHO criteria

2. are aged 18 years or over

3. 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:

1. with mental incapacity to give informed consent,

2. 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

3. with significant peripheral arterial disease (PAD): ABPI (ankle brachial pressure index) <0.7,

4. Who have osteomyelitis defined by agreed clinical criteria

5. who are receiving treatment with systemic glucocorticoids or other immunosuppressants,

6. who have received systemic or topical antibiotics in the preceding 14 days,

7. who are judged to require parenteral administration of antibiotics,

8. Who have been previously recruited to an earlier part of the project

9. who are women of childbearing age who are at risk of conception

10. History of antibiotic hypersensitivity