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Funding issues meant that development of the study was halted.
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| Name | Class |
|---|---|
| Wellcome Trust | OTHER |
| BioPhage Theraputics Limited | UNKNOWN |
| Nottingham University Hospitals NHS Trust | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phage | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phage | Drug | 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. |
| 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. | - 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 | 7 months |
| Work Package 2 | 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 | 16 months |
| Work Package 3 | 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. | 16 months |
| Measure | Description | Time Frame |
|---|---|---|
| Work Package 1: Safety of phage gel and overt toxic effect of phage gel. | The following outcomes will be recorded at weekly intervals for 4 weeks from baseline:
|
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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:
Exclusion Criteria:
We will exclude patients who meet ANY of the following criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Derby and Burton NHS Foundation Trust | Derby | Derbyshire | DE22 3DT | United Kingdom |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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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
|
| 7 months |
| Work Package 1: • Impact on the bacterial microbiome of anti-staphylococcal phage gel and systemically chosen antibiotics. | 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. | 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. | 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. | 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. | 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. | 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. | The following outcomes will be recorded at weekly intervals for 4 weeks from baseline:
| 16 months |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003929 | Diabetic Neuropathies |