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    Clinical Trial Results:
    A prospective single blind randomised controlled study to compare the outcomes of patients with diabetes and clinically non-infected ischaemic and neuropathic foot ulcers treated with and without oral antibiotics - KADFUT

    Summary
    EudraCT number
    		 2010-022518-16
    Trial protocol
    		 GB  
    Global end of trial date
    15 Jan 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Aug 2020
    First version publication date
    27 Aug 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    KADFUT
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    King's College Hospital NHS Foundation Trust
    Sponsor organisation address
    Denmark Hill, London, United Kingdom, SE5 9RS
    Public contact
    Diabetic Foot Clinic, King's College Hospital , +44 020 3299 3223, mbates2@nhs.net
    Scientific contact
    Diabetic Foot Clinic, King's College Hospital , +44 020 3299 3223, mbates2@nhs.net
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    13 Aug 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Jan 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jan 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The overall objective is to investigate whether antibiotics in the treatment of clinically clean neuropathic and ischaemic ulcers in diabetic foot patients could reduce the incidence of infection and therefore lead to improved outcomes .
    Protection of trial subjects
    Patients are free to withdraw consent for study treatment and/or consent to participate in the study at any time and without the prejudice to further treatment. Patients who withdraw from study treatment, but are willing to continue to participate in the follow-up visits, should be followed according to the procedures outlined in the protocol. Patients who develop clinical signs and symptoms of infection in their target or other foot ulcer will be withdrawn. At withdrawal data will be collected as described in the ‘early termination visit’ and patients followed up 14 days later as per the ‘post treatment evaluation’. Patients who develop drug related adverse events such as gastro intestinal side effects including diarrhoea and vomiting that continue for more than 72 hrs and prevent them from taking antibiotics will also be withdrawn from the study. Patients who develop previously unknown allergies to antibiotics will be withdrawn from the study.
    Background therapy
    		 Standard of care treatment for diabetic foot ulceration without clinical signs of infection. It is generally recommended that patients with ulcers but no purulence should not be treated with antibiotics
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Apr 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 16
    Worldwide total number of subjects
    16
    EEA total number of subjects
    16
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    16
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited over a period of 21 months at KCH. First Patient first visit (FPFV) 30/04/2012. Between January 2012 to October 2012 no recruitment took place. The trial was terminated before the recruitment target was reached due to slow recruitment, lack of personnel and resources and recruitment had not taken place since 2013.

    Pre-assignment
    Screening details
    		 Patients with type 1 or 2 diabetes mellitus, who presented to the Diabetic Foot Clinic at KCH with clean neuropathic or ischaemic diabetic foot ulcers without clinical signs of infection. Patients were recruited over a period of 21 months. Including patients referred from GP surgeries, Primary Care Trusts and other hospitals.

    Pre-assignment period milestones
    Number of subjects started
    		 17 [1]
    Number of subjects completed
    		 16

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 screen fail: 1
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The pre-assignment period includes 1 screen fail who was not enrolled into the study
    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Assessor [2]
    Blinding implementation details
    Both patients and the Chief Investigator will know the treatment group, however there will be a blinded research team for assessments. Patients will be advised that there will always be two teams of health care professionals monitoring them: the blinded team and the unblinded team .The patient will be asked not to inform the blinded team as to which group they belong.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Active group
    Arm description
    		 antibiotics + standard care The IMPs are licensed antibiotics. Amoxycillin 500mg /250mg capsules Flucloxacillin 500mg/250mg capsules Ciprofloxacin 500mg/250mg tablets Metronidazole 400mg/200mg tablets Clarithromycin 500mg/250mg tablets The above antibiotics will be used for the initial treatment of the patient in the antibiotic group. On follow up visits, patients may continue with their initial antibiotics as prescribed or antibiotics may be adjusted according to the microbiology results of the ulcer culture and microbial sensitivity/resistance (see below). These results are reviewed weekly and antibiotics are changed if necessary. Doxycycline 100mg capsules Trimethoprim 200mg/100mg tablets Sodium fusidate 250mg tablets Rifampicin 300mg capsules Co-amoxiclav 625mg/375mg tablets Co-trimoxazole 480mg Clindamycin 150mg capsules Linezolid 600mg tablets Ceftriaxone sodium 1Gm Ceftazidime pentahydrate 1Gm Teicoplanin 400mg/200mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    amoxicillin trihydrate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    1.5 g per day for up to 20 weeks

    Investigational medicinal product name
    flucloxacillin sodium
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    2g per day for up to 20 weeks

    Investigational medicinal product name
    metronidazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1.2g per day for up to 20 weeks

    Investigational medicinal product name
    ciprofloxacin hydrochloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1g per day for up to 20 weeks

    Investigational medicinal product name
    doxycycline hyclate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    100mg per day for up to 19 weeks

    Investigational medicinal product name
    trimethoprim
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400mg per day for up to 19 weeks

    Investigational medicinal product name
    sodium fusidate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1.5g per day for up to 19 weeks

    Investigational medicinal product name
    rifampicin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    1200 per day for up to 19 weeks

    Investigational medicinal product name
    co-amoxiclav
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1.875g per day for up to 19 weeks

    Investigational medicinal product name
    clindamycin hydrochloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    1.2g per day for up to 19 weeks

    Investigational medicinal product name
    clarithromycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1g per day for up to 20 weeks

    Investigational medicinal product name
    ceftriaxone sodium
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1g dissolved in 3.5 ml 1% lignocaine for up to 2 weeks

    Investigational medicinal product name
    linezolid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1.2g per day for up to 4 weeks

    Investigational medicinal product name
    ceftazidime pentahydrate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3g dissolved in 3.0 ml 1% lignocaine per day for up to 2 weeks

    Investigational medicinal product name
    teicoplanin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    400mg dissolved in 3.0mls sterile water per day for up to 2 weeks

    Investigational medicinal product name
    co trimoxazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1.920g per day for up to 19 weeks

    Arm title
    		 Control group
    Arm description
    		 Received standard care for clinically non-infected ischaemic and neuropathic foot ulcers
    Arm type
    		 standard of care

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Notes
    [2] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: There was a blinded research team who performed assessments. The patient and investigator were unblinded.
    Number of subjects in period 1
    		Active group Control group
    Started
    7
    9
    Completed
    3
    5
    Not completed
    4
    4
         Adverse event, non-fatal
    4
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Active group
    Reporting group description
    		 antibiotics + standard care The IMPs are licensed antibiotics. Amoxycillin 500mg /250mg capsules Flucloxacillin 500mg/250mg capsules Ciprofloxacin 500mg/250mg tablets Metronidazole 400mg/200mg tablets Clarithromycin 500mg/250mg tablets The above antibiotics will be used for the initial treatment of the patient in the antibiotic group. On follow up visits, patients may continue with their initial antibiotics as prescribed or antibiotics may be adjusted according to the microbiology results of the ulcer culture and microbial sensitivity/resistance (see below). These results are reviewed weekly and antibiotics are changed if necessary. Doxycycline 100mg capsules Trimethoprim 200mg/100mg tablets Sodium fusidate 250mg tablets Rifampicin 300mg capsules Co-amoxiclav 625mg/375mg tablets Co-trimoxazole 480mg Clindamycin 150mg capsules Linezolid 600mg tablets Ceftriaxone sodium 1Gm Ceftazidime pentahydrate 1Gm Teicoplanin 400mg/200mg

    Reporting group title
    Control group
    Reporting group description
    		 Received standard care for clinically non-infected ischaemic and neuropathic foot ulcers

    Reporting group values
    		 Active group Control group Total
    Number of subjects
    		 7 9 16
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 57 ( 7.1 ) 65.4 ( 10.6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 1 0 1
        Male
    		 6 9 15
    Type of diabetes
    Units: Subjects
        Type 1 DM
    		 1 0 1
        Type 2 DM
    		 6 9 15
    Neuropathic: neuroischaemic
    Units: Subjects
        Neuropathic
    		 6 9 15
        Neuroischaemic
    		 1 0 1
    Target ulcer
    Units: Subjects
        Right Foot
    		 3 3 6
        Left Foot
    		 4 6 10
    Duration of diabetes
    Units: Years
        arithmetic mean (standard deviation)
    		 14 ( 4.6 ) 13.7 ( 8.7 ) -
    Ulcer area at presentation
    Units: cm2
        arithmetic mean (standard deviation)
    		 1.2 ( 1.1 ) 2.1 ( 2.4 ) -

    End points

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    End points reporting groups
    Reporting group title
    Active group
    Reporting group description
    		 antibiotics + standard care The IMPs are licensed antibiotics. Amoxycillin 500mg /250mg capsules Flucloxacillin 500mg/250mg capsules Ciprofloxacin 500mg/250mg tablets Metronidazole 400mg/200mg tablets Clarithromycin 500mg/250mg tablets The above antibiotics will be used for the initial treatment of the patient in the antibiotic group. On follow up visits, patients may continue with their initial antibiotics as prescribed or antibiotics may be adjusted according to the microbiology results of the ulcer culture and microbial sensitivity/resistance (see below). These results are reviewed weekly and antibiotics are changed if necessary. Doxycycline 100mg capsules Trimethoprim 200mg/100mg tablets Sodium fusidate 250mg tablets Rifampicin 300mg capsules Co-amoxiclav 625mg/375mg tablets Co-trimoxazole 480mg Clindamycin 150mg capsules Linezolid 600mg tablets Ceftriaxone sodium 1Gm Ceftazidime pentahydrate 1Gm Teicoplanin 400mg/200mg

    Reporting group title
    Control group
    Reporting group description
    		 Received standard care for clinically non-infected ischaemic and neuropathic foot ulcers

    Primary: Healing at week 20

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    End point title
    		 Healing at week 20 [1]
    End point description
    patients in each group that are healed at 20 weeks. Healing will be defined as complete epithelialisation which should be present on 2 consecutive weeks.
    End point type
    Primary
    End point timeframe
    week 20
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: In view of the low numbers of subjects recruited , Analysis of Efficacy Variables was not carried out
    End point values
    		 Active group Control group
    Number of subjects analysed
    7
    9
    Units: Subjects
        Healed
    3
    5
    No statistical analyses for this end point

    Secondary: Time to healing of foot ulceration

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    End point title
    		 Time to healing of foot ulceration
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to 20 weeks
    End point values
    		 Active group Control group
    Number of subjects analysed
    3
    5
    Units: Weeks
    arithmetic mean (standard deviation)
        Healed
    8.7 ( 6.5 )
    6.8 ( 3.2 )
    No statistical analyses for this end point

    Secondary: develop clinical signs of foot infection

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    End point title
    		 develop clinical signs of foot infection
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to 20 weeks
    End point values
    		 Active group Control group
    Number of subjects analysed
    7
    9
    Units: Subjects
        Developed clinical signs of foot infection
    2
    4
    No statistical analyses for this end point

    Secondary: Number of hospital admissions related to the foot ulcer

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    End point title
    		 Number of hospital admissions related to the foot ulcer
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to 20 weeks
    End point values
    		 Active group Control group
    Number of subjects analysed
    7
    7
    Units: Subjects
        Admitted to hospital
    0
    2
    No statistical analyses for this end point

    Secondary: Number of amputations

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    End point title
    		 Number of amputations
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to 20 weeks
    End point values
    		 Active group Control group
    Number of subjects analysed
    7
    9
    Units: Subjects
        Amputations
    0
    0
    No statistical analyses for this end point

    Secondary: Adverse effects of antibiotic treatment

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    End point title
    		 Adverse effects of antibiotic treatment
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to 20 weeks
    End point values
    		 Active group Control group
    Number of subjects analysed
    7
    9
    Units: Subjects
        Adverse event related to antibiotic treatment
    2
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline to week 20
    Adverse event reporting additional description
    Adverse events will be noted and assessed at weekly visits by the unblinded team
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    32
    Reporting groups
    Reporting group title
    Active group
    Reporting group description
    		 antibiotics + standard care The IMPs are licensed antibiotics. Amoxycillin 500mg /250mg capsules Flucloxacillin 500mg/250mg capsules Ciprofloxacin 500mg/250mg tablets Metronidazole 400mg/200mg tablets Clarithromycin 500mg/250mg tablets The above antibiotics will be used for the initial treatment of the patient in the antibiotic group. On follow up visits, patients may continue with their initial antibiotics as prescribed or antibiotics may be adjusted according to the microbiology results of the ulcer culture and microbial sensitivity/resistance (see below). These results are reviewed weekly and antibiotics are changed if necessary. Doxycycline 100mg capsules Trimethoprim 200mg/100mg tablets Sodium fusidate 250mg tablets Rifampicin 300mg capsules Co-amoxiclav 625mg/375mg tablets Co-trimoxazole 480mg Clindamycin 150mg capsules Linezolid 600mg tablets Ceftriaxone sodium 1Gm Ceftazidime pentahydrate 1Gm Teicoplanin 400mg/200mg

    Reporting group title
    Control group
    Reporting group description
    		 Received standard care for clinically non-infected ischaemic and neuropathic foot ulcers

    Serious adverse events
    		 Active group Control group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 7 (14.29%)
    2 / 9 (22.22%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Renal and urinary disorders
    acute renal failure
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    infected foot ulcer
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 9 (22.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Active group Control group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 7 (100.00%)
    7 / 9 (77.78%)
    Nervous system disorders
    Vertigo
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Vision blurred
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    Haemorrhage
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 7 (28.57%)
    1 / 9 (11.11%)
         occurrences all number
    2
    1
    Vomiting
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    Nausea
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    Constipation
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    Respiratory, thoracic and mediastinal disorders
    dry cough
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    Skin and subcutaneous tissue disorders
    Blister
         subjects affected / exposed
    1 / 7 (14.29%)
    2 / 9 (22.22%)
         occurrences all number
    1
    2
    toe bruising
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    pain in hip
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    Infections and infestations
    foot infection
         subjects affected / exposed
    2 / 7 (28.57%)
    3 / 9 (33.33%)
         occurrences all number
    2
    0
    Cold/flu
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 9 (0.00%)
         occurrences all number
    3
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Dec 2011
    Protocol updated as follows: Inclusion Criteria: Contraception updated to ensure only contraception that is not affected by enzyme inducing antibacterials such as rifampicin is used. Alternatively a barrier method may be added to the original contraceptive method has been added. Exclusion Criteria: Patients who are allergic to Penicillin can be randomised into the trial. Duration of trial updated. Clarifications and administrative changes.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    As it was only possible to recruit 17 patients to this study, it is not possible to reach a conclusion regarding the outcomes of patients with diabetes& clinically non-infected ischaemic&neuropathic foot ulcers treated with & without oral antibiotics
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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