Clinical Trial Results:
The effect of subcutaneous injection of Botulinum Toxin A on chronic wound pain in lower extremities, a prospective exploratory study
Summary
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EudraCT number |
2021-000096-36 |
Trial protocol |
DK |
Global end of trial date |
22 Apr 2024
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Results information
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Results version number |
v1(current) |
This version publication date |
28 Apr 2025
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First version publication date |
28 Apr 2025
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
Botox-01
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT05426161 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Bispebjerg Hospital
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Sponsor organisation address |
Bispebjerg Bakke 23, Copenhagen , Denmark, 2400
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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
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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
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
19 Jun 2024
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
22 Apr 2024
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Global end of trial reached? |
Yes
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Global end of trial date |
22 Apr 2024
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Was the trial ended prematurely? |
Yes
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General information about the trial
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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.
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Protection of trial subjects |
Monitoring and recording all adverse events (pre-defined or not) throughout the duration of the study.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Jun 2021
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Denmark: 10
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Worldwide total number of subjects |
10
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EEA total number of subjects |
10
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
3
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From 65 to 84 years |
6
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85 years and over |
1
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Recruitment
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Recruitment details |
- | ||||||
Pre-assignment
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Screening details |
Patients with painful lower extremity wounds for at least 4 weeks with VAS score of 30 mm or more. | ||||||
Period 1
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Period 1 title |
Overall trail (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Arms
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Arm title
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Total | ||||||
Arm description |
- | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Botox
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and solution for solution for injection
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Routes of administration |
Subcutaneous use
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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
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Baseline characteristics reporting groups
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Reporting group title |
Overall trail
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Subject analysis set
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
All the patients included in the trail.
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End points reporting groups
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Reporting group title |
Total
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Reporting group description |
- | ||
Subject analysis set title |
Subject analysis set
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
All the patients included in the trail.
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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.
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End point type |
Primary
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End point timeframe |
3 weeks after botulinum neurotoxin A injection.
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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. |
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
From the inclusion in the study af the baseline visit to the final visit (3 months after).
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Adverse event reporting additional description |
Adverse event was assessed during each visit.
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Assessment type |
Non-systematic | ||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||
Dictionary version |
10
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Reporting groups
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Reporting group title |
Overall trail
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Reporting group description |
- | ||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 1% | |||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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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). |