Diabetes Clinical Trial
— PDFIOfficial title:
Assessing the Efficacy of Anti-staphylococcal Phages in the Management of Infected Foot Ulcers in Diabetes
Verified date | February 2020 |
Source | University Hospitals of Derby and Burton NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 1, 2022 |
Est. primary completion date | June 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University Hospitals Derby and Burton NHS Foundation Trust | Derby | Derbyshire |
Lead Sponsor | Collaborator |
---|---|
University Hospitals of Derby and Burton NHS Foundation Trust | BioPhage Theraputics Limited, Nottingham University Hospitals NHS Trust, Wellcome Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Secondary | 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: Incidence of new infection Number of days of antibiotic usage Change in surface microbiome Adverse events Change in safety bloods, vital signs, FBC, renal function, CRP, LFTs Wound status (clinical infection, area, depth, extent of surface slough, pain by VAS, peri ulcer appearance) Patient well-being using a Visual Analogue Scale, 0-100mm. Vital signs (Resting pulse and blood pressure (BP)) |
7 months | |
Secondary | 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: Incidence of new infection Number of days of antibiotic usage Change in surface microbiome Adverse events Change in safety bloods, vital signs, FBC, renal function, CRP, LFTs Wound status (clinical infection, area, depth, extent of surface slough, pain by VAS, peri ulcer appearance) Patient well-being using a Visual Analogue Scale, 0-100mm. Vital signs (Resting pulse and blood pressure (BP)) |
7 months | |
Secondary | 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: change in surface microbiome Number of antibiotic-free days Adverse events Change in safety bloods, vital signs, FBC, renal function, CRP, LFTs Wound status (clinical infection, area, depth, extent of surface slough, pain by VAS, peri ulcer appearance) Patient well-being using a Visual Analogue Scale, 0-100mm. Eradication of clinical evidence of the infection in the index ulcer at weeks 1, 2 and 3, and time to eradication Healing of all ulcers and time to healing Resting pulse and blood pressure (BP) |
7 months | |
Secondary | 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: change in surface microbiome Number of antibiotic-free days Adverse events Change in safety bloods, vital signs, FBC, renal function, CRP, LFTs Wound status (clinical infection, area, depth, extent of surface slough, pain by VAS, peri ulcer appearance) Patient well-being using a Visual Analogue Scale, 0-100mm. Eradication of clinical evidence of the infection in the index ulcer at weeks 1, 2 and 3, and time to eradication Healing of all ulcers and time to healing Resting pulse and blood pressure (BP) |
16 months | |
Secondary | 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: change in surface microbiome Number of antibiotic-free days Adverse events Change in safety bloods, vital signs, FBC, renal function, CRP, LFTs Wound status (clinical infection, area, depth, extent of surface slough, pain by VAS, peri ulcer appearance) Patient well-being using a Visual Analogue Scale, 0-100mm. Eradication of clinical evidence of the infection in the index ulcer at weeks 1, 2 and 3, and time to eradication Healing of all ulcers and time to healing Resting pulse and blood pressure (BP) |
16 months | |
Secondary | 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: Change in surface microbiome Number of antibiotic-free days Adverse events Change in safety bloods, FBC, renal function, CRP, LFTs Wound status (clinical infection, area, depth, extent of surface slough, pain by VAS, peri ulcer appearance) Patient well-being using a Visual Analogue Scale, 0-100mm. Eradication of clinical evidence of the infection in the index ulcer at weeks 1, 2 and 3, and time to eradication Healing of all ulcers and time to healing Resting pulse and blood pressure (BP) |
16 months | |
Secondary | 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: Change in surface microbiome Number of antibiotic-free days Adverse events Change in safety bloods, FBC, renal function, CRP, LFTs Wound status (clinical infection, area, depth, extent of surface slough, pain by VAS, peri ulcer appearance) Patient well-being using a Visual Analogue Scale, 0-100mm. Eradication of clinical evidence of the infection in the index ulcer at weeks 1, 2 and 3, and time to eradication Healing of all ulcers and time to healing Resting pulse and blood pressure (BP) |
16 months | |
Secondary | 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: Change in surface microbiome Number of antibiotic-free days Adverse events Change in safety bloods, FBC, renal function, CRP, LFTs Wound status (clinical infection, area, depth, extent of surface slough, pain by VAS, peri ulcer appearance) Patient well-being using a Visual Analogue Scale, 0-100mm. Eradication of clinical evidence of the infection in the index ulcer at weeks 1, 2 and 3, and time to eradication Healing of all ulcers and time to healing Resting pulse and blood pressure (BP) |
16 months |
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