Status:
COMPLETED
The Effect of Subcutaneous Injection of Botulinum Toxin A on Chronic Wound Pain in Lower Extremities
Lead Sponsor:
Bispebjerg Hospital
Conditions:
Chronic Pain
Lower Extremity Wound
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 23 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05426161
Start Date
February 7 2023
End Date
April 23 2024
Last Update
August 9 2024
Active Locations (1)
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1
Department of Dermatology and Copenhagen Wound Healing Center, Bispebjerg Hospital
Copenhagen, Denmark