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    Clinical Trial Results:
    The effect of subcutaneous injection of Botulinum Toxin A on chronic wound pain in lower extremities, a prospective exploratory study

    Summary
    EudraCT number
    		 2021-000096-36
    Trial protocol
    		 DK  
    Global end of trial date
    22 Apr 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Apr 2025
    First version publication date
    28 Apr 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Botox-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05426161
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bispebjerg Hospital
    Sponsor organisation address
    Bispebjerg Bakke 23, Copenhagen , Denmark, 2400
    Public contact
    Department of Dermatology and Copenhagen Wound Healing Center, Bispebjerg Hospital, Department of Dermatology and Copenhagen Wound Healing Center, Bispebjerg Hospital, lubna.sabah@regionh.dk
    Scientific contact
    Department of Dermatology and Copenhagen Wound Healing Center, Bispebjerg Hospital, Department of Dermatology and Copenhagen Wound Healing Center, Bispebjerg Hospital, lubna.sabah@regionh.dk
    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
    19 Jun 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Apr 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Apr 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The aim of the study is to investigate the effect of subcutaneous administration of Botulinum neurotoxin A on chronic wound pain and wound healing in lower extremity ulcer and safety of the treatment.
    Protection of trial subjects
    Monitoring and recording all adverse events (pre-defined or not) throughout the duration of the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 2021
    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
    Denmark: 10
    Worldwide total number of subjects
    10
    EEA total number of subjects
    10
    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)
    3
    From 65 to 84 years
    6
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Patients with painful lower extremity wounds for at least 4 weeks with VAS score of 30 mm or more.

    Period 1
    Period 1 title
    Overall trail (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Total
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Botox
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    10 units of Botox per cm2 wound area were injected around the wound (2-4 injection sites), 1-2 cm from the wound edge subcutaneously

    Number of subjects in period 1
    		Total
    Started
    10
    Completed
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trail
    Reporting group description
    		 -

    Reporting group values
    		 Overall trail Total
    Number of subjects
    		 10 10
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 3 3
        From 65-84 years
    		 6 6
        85 years and over
    		 1 1
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 70 (46 to 86) -
    Gender categorical
    Units: Subjects
        Female
    		 4 4
        Male
    		 6 6
    Subject analysis sets

    Subject analysis set title
    Subject analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All the patients included in the trail.

    Subject analysis sets values
    		 Subject analysis set
    Number of subjects
    10
    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)
    3
        From 65-84 years
    6
        85 years and over
    1
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    70 (46 to 86)
    Gender categorical
    Units: Subjects
        Female
    4
        Male
    6

    End points

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    End points reporting groups
    Reporting group title
    Total
    Reporting group description
    		 -

    Subject analysis set title
    Subject analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All the patients included in the trail.

    Primary: Primary end point

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    End point title
    		 Primary end point [1]
    End point description
    The proportion of patients whose pain score (mean Visual analogue scale (VAS) score for study day 18-20) decreased by the predefined level of ≥ 20 mm from baseline (before botulinum neurotoxin A injection) to 3 weeks after injection.
    End point type
    Primary
    End point timeframe
    3 weeks after botulinum neurotoxin A injection.
    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: Descriptive and statistical analyses were performed using SPSS Statistics. Continuous data were presented by mean and standard deviation (SD) or median and interquartile ranges (IQR), while categorical variables were expressed in proportions and percentages. The Wilcoxon signed-rank test and Spearman's correlation coefficient (r) were used. Statistical significance was defined as p < 0.05.
    End point values
    		 Total Subject analysis set
    Number of subjects analysed
    10
    10
    Units: number
        Reduction in VAS ≥ 20 mm
    7
    7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the inclusion in the study af the baseline visit to the final visit (3 months after).
    Adverse event reporting additional description
    Adverse event was assessed during each visit.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Overall trail
    Reporting group description
    		 -

    Serious adverse events
    		 Overall trail
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 10 (30.00%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    0
    Surgical and medical procedures
    hospitalization
         subjects affected / exposed
    3 / 10 (30.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Overall trail
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 10 (70.00%)
    Skin and subcutaneous tissue disorders
    Eczema, skin infection, feber
         subjects affected / exposed
    7 / 10 (70.00%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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.
    Early termination of the trail due to recruitment difficulties leading to small number of subjects analysed (10 only i stead of 13).
    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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