Clinical study
PDFI
Assessing the Efficacy of Anti-staphylococcal Phages in the Management of Infected Foot Ulcers in Diabetes
| Status | Withdrawn |
|---|---|
| Type | Trial |
| Countries | United Kingdom |
| Conditions studied | Diabetes; Diabetic Foot; Diabetic Foot Infection |
| Study years | 2019 (estimated)–2022 (estimated) |
| Entry review | 2026-10-03 |
Participation
Check the study record or contact the study team for current recruitment and eligibility.
Study eligibility
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
Study description
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
Study registrations
| ClinicalTrials.gov | NCT04289948 |
|---|
Recorded study locations (1)
Locations listed in the study record; this does not confirm current recruitment or treatment outside the study. A site label may be older than the overall study status.
University Hospitals Derby and Burton NHS Foundation Trust
Derby, Derbyshire, United Kingdom
Recorded site status: Not separately listed. Study location source ↗
Sources and updates
Entry reviewed . This is the date of our source review, not a confirmation of availability today.
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| Study ID | nct04289948 |
|---|