Chronic PainPhase 4NCT05426161
The Effect of Subcutaneous Injection of Botulinum Toxin A on Chronic Wound Pain in Lower Extremities
A Phase 4 study testing Botulinum Toxin A in people with Chronic Pain and Lower Extremity Wound, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
The aim of the study is to investigate the effect of subcutaneous administration of Botulinum toxin A on wound pain, wound healing and safety of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Lower Extremity Wound
- What is being tested?
- Botulinum Toxin A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 7 Feb 2023to 23 Apr 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old.
- Lower extremity ulcer ≥ 4 weeks.
- Ulcer area ≥ 1,5 cm2 and ≤ 20 cm2
- Patients with neuropathic pain related to the ulcer (daily VAS pain scores ≥ 30 mm at rest and DN4 score ≥ 4).
- Normal monofilament and vibration test in lower extremities.
- Patients who can fill out pain diary correctly.
- Written informed consent to participate in the study after having fully understood the contents of the protocol and restrictions.
Who cannot join
- 1. Infection at injection site. 2. Hypersensitivity to botulinum toxin A. 3. Peripheral neuropathy. 3. Diabetic foot ulcer. 4. Unstable critic peripheral ischemia judged by investigator 5. Exposed capsule, tendon, muscle or bone in the ulcers. 6. Tunnelling, undermining or sinus tracts. 7. Disorders of the neuromuscular junction (e.g. Myasthenia). 8. Topical analgesic (e.g Biatain ibu or Lidocain) within 7 days before inclusion.
- 9. Pregnant or lactating woman and woman with childbearing potential but does not use contraception.
- 10. Judgment by the investigator that the patient is not suited for study participation.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Dermatology and Copenhagen Wound Healing Center, Bispebjerg Hospital
Copenhagen
About this study
Official title: The Effect of Subcutaneous Injection of Botulinum Toxin A on Chronic Wound Pain in Lower Extremities, a Prospective Exploratory Study
The aim of the study is to investigate the effect of subcutaneous administration of Botulinum toxin A on wound pain, wound healing and safety of treatment.
- Conditions
- Chronic Pain, Lower Extremity Wound
- Being tested
- Botulinum Toxin A
- Keywords
- Botulinum toxin A
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin ADrug
Botulinum Toxin A (10 units per cm2 wound areal) will be injected subcutaneously around the wound (1-2 cm from wound edge) maximum 200 units at each injection time.The total dose of BoNTA is maximum 400 units. Patient will receive one or two treatments in total.
| Study group | Role | What they receive |
|---|---|---|
| Botulinum Toxin A | Experimental | Open-label study Receives: Drug: Botulinum Toxin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients reaching a reduction in mean visual analog scale (VAS) > 20 mm (at rest) in dynamic pain scores at study day 21 or 41
At study day 0 the mean VAS will be calculated at rest for D-2-0 and at D21 or D41 mean VAS will be calculated for D19-21 or D39-41
Measured: 3 to 6 weeks after first injection of Botulinum toxin a
Secondary outcomes (6)
Absolute and percentage change in the area of hyperalgesia and allodynia
Area of hyperalgesia and allodynia will be assessed at D0, D21/41 and D90/110
Measured: 3 to15 weeks after first injection of Botulinum toxin a.
Absolute and percentage change of the ulcer area.
The ulcer size will be measured at every visit with study day 0 as baseline.
Measured: Throughout the trial (12-15 weeks)
Clinical improvement of the wound healing process
Semi-quantitatively measured (major improvement, minor improvement, status quo or worsening)
Measured: Throughout the trial (12-15 weeks)
Therapeutic doses of Botulinum toxin a to treat wound pain
Number of patients who need a second injection of Botulinum toxin a on study D21 if mean VAS (D19-21) are similar (± 10 %) to the pre-injection mean VAS at D0
Measured: 3 and 6 weeks after first injection
Incidence of Treatment-Emergent Adverse Events
All clinical adverse events will be assessed and recorded.
Measured: Throughout the trial (12-15 weeks)
Exploratory measurement: Changes in the levels of cytokines and pain related substances in the wound fluid before and after injection with Botulinum toxin a
Changes in the levels of cytokine and pain related substances will be quantified over time (throughout the trial). Prospects to analyse i.g ( IL-6, NGF, IL-1β) with either MSD,Luminex or ELISA.
The results will be expressed as pg/ mg.
Measured: Analysis within 1 year after study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start7 Feb 2023
- Primary completion23 Apr 2024
- Study completion23 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single-center, prospective, exploratory study
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lubna Sabah, MD, Bispebjerg Hospital
- Investigators
- Simon Francis Thomsen, Professor, Study director, Department of Dermatology and Copenhagen Wound Healing Center, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05426161
- Sponsor's protocol ID
- Botox-01
- Status last verified
- Aug 2024
- First submitted
- 14 Jun 2022
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Subcutaneous Injection of Botulinum Toxin A on Chronic Wound Pain in Lower Extremities, a Prospective Exploratory Study
- ClinicalTrials.gov ID
- NCT05426161
- Acronym / sponsor ID
- Botox-01
- Conditions
- Chronic Pain, Lower Extremity Wound
- Keywords
- Botulinum toxin A
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 23 Apr 2024 (actual)
- Study completion
- 23 Apr 2024 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to investigate the effect of subcutaneous administration of Botulinum toxin A on wound pain, wound healing and safety of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single-center, prospective, exploratory study
| Arm | Type | Receives |
|---|---|---|
| Botulinum Toxin A | Experimental | Drug: Botulinum Toxin AOpen-label study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years old.
- Lower extremity ulcer ≥ 4 weeks.
- Ulcer area ≥ 1,5 cm2 and ≤ 20 cm2
- Patients with neuropathic pain related to the ulcer (daily VAS pain scores ≥ 30 mm at rest and DN4 score ≥ 4).
- Normal monofilament and vibration test in lower extremities.
Key exclusion criteria (3 listed)
- 1. Infection at injection site. 2. Hypersensitivity to botulinum toxin A. 3. Peripheral neuropathy. 3. Diabetic foot ulcer. 4. Unstable critic peripheral ischemia judged by investigator 5. Exposed capsule, tendon, muscle or bone in the ulcers. 6. Tunnelling, undermining or sinus tracts. 7. Disorders of the neuromuscular junction (e.g. Myasthenia). 8. Topical analgesic (e.g Biatain ibu or Lidocain) within 7 days before inclusion.
- 9. Pregnant or lactating woman and woman with childbearing potential but does not use contraception.
- 10. Judgment by the investigator that the patient is not suited for study participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum Toxin ABotulinum Toxin A (10 units per cm2 wound areal) will be injected subcutaneously around the wound (1-2 cm from wound edge) maximum 200 units at each injection time.The total dose of BoNTA is maximum 400 units. Patient will receive one or two treatments in total. | Drug | Botulinum Toxin A |
Primary outcome
Proportion of patients reaching a reduction in mean visual analog scale (VAS) > 20 mm (at rest) in dynamic pain scores at study day 21 or 41
Time frame: 3 to 6 weeks after first injection of Botulinum toxin a
At study day 0 the mean VAS will be calculated at rest for D-2-0 and at D21 or D41 mean VAS will be calculated for D19-21 or D39-41
6 secondary outcomes
Absolute and percentage change in the area of hyperalgesia and allodynia
Time frame: 3 to15 weeks after first injection of Botulinum toxin a.
Absolute and percentage change of the ulcer area.
Time frame: Throughout the trial (12-15 weeks)
Clinical improvement of the wound healing process
Time frame: Throughout the trial (12-15 weeks)
Therapeutic doses of Botulinum toxin a to treat wound pain
Time frame: 3 and 6 weeks after first injection
Incidence of Treatment-Emergent Adverse Events
Time frame: Throughout the trial (12-15 weeks)
Exploratory measurement: Changes in the levels of cytokines and pain related substances in the wound fluid before and after injection with Botulinum toxin a
Time frame: Analysis within 1 year after study completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Francis Thomsen, Professor study director
Department of Dermatology and Copenhagen Wound Healing Center, Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Botulinum Toxin A in people with Chronic Pain and Lower Extremity Wound, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients reaching a reduction in mean visual analog scale (VAS) > 20 mm (at rest) in dynamic pain scores at study day 21 or 41 (time frame: 3 to 6 weeks after first injection of Botulinum toxin a). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.