Clinical trial NCT05426161: The Effect of Subcutaneous Injection of Botulinum Toxin A on Chronic Wound Pain in Lower Extremities
Official title: The Effect of Subcutaneous Injection of Botulinum Toxin A on Chronic Wound Pain in Lower Extremities, a Prospective Exploratory Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Pain
Lower Extremity Wound
Keywords: Botulinum toxin A
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single-center, prospective, exploratory study
Primary purpose: TREATMENT

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 Criteria:

1. Age ≥ 18 years old.
2. Lower extremity ulcer ≥ 4 weeks.
3. Ulcer area ≥ 1,5 cm2 and ≤ 20 cm2
4. Patients with neuropathic pain related to the ulcer (daily VAS pain scores ≥ 30 mm at rest and DN4 score ≥ 4).
5. Normal monofilament and vibration test in lower extremities.
6. Patients who can fill out pain diary correctly.
7. Written informed consent to participate in the study after having fully understood the contents of the protocol and restrictions.

Exclusion Criteria:

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.

Primary outcomes:
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
timeFrame: 3 to 6 weeks after first injection of Botulinum toxin a
Secondary outcomes:
measure: Absolute and percentage change in the area of hyperalgesia and allodynia
timeFrame: 3 to15 weeks after first injection of Botulinum toxin a.
measure: Absolute and percentage change of the ulcer area.
timeFrame: Throughout the trial (12-15 weeks)
measure: Clinical improvement of the wound healing process
timeFrame: Throughout the trial (12-15 weeks)
measure: Therapeutic doses of Botulinum toxin a to treat wound pain
timeFrame: 3 and 6 weeks after first injection
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Throughout the trial (12-15 weeks)
measure: Exploratory measurement: Changes in the levels of cytokines and pain related substances in the wound fluid before and after injection with Botulinum toxin a
timeFrame: Analysis within 1 year after study completion
Other outcomes:
measure: Wound status- Degree of inflammation, granulation tissue, necrosis/slough, exudation and infection.
timeFrame: Throughout the trial (12-15 weeks)
Locations:
city: Copenhagen
country: Denmark
facility: Department of Dermatology and Copenhagen Wound Healing Center, Bispebjerg Hospital
Study officials:
affiliation: Department of Dermatology and Copenhagen Wound Healing Center, Bispebjerg Hospital
name: Simon Francis Thomsen, Professor
role: STUDY_DIRECTOR
References: