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Completed

NCT Number: NCT05426161

The Effect of Subcutaneous Injection of Botulinum Toxin A on Chronic Wound Pain in Lower Extremities

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.

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Key information

Conditions

Chronic Pain Lower Extremity Wound Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Dermatology and Copenhagen Wound Healing Center, Bispebjerg Hospital

Copenhagen, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.
  • Pregnant or lactating woman and woman with childbearing potential but does not use contraception.
  • Judgment by the investigator that the patient is not suited for study participation.

Treatment and study plan

Botulinum toxin A

Drug

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Absolute and percentage change in the area of hyperalgesia and allodynia

    Time frame: 3 to15 weeks after first injection of Botulinum toxin a.

    Area of hyperalgesia and allodynia will be assessed at D0, D21/41 and D90/110

  2. Absolute and percentage change of the ulcer area.

    Time frame: Throughout the trial (12-15 weeks)

    The ulcer size will be measured at every visit with study day 0 as baseline.

  3. Clinical improvement of the wound healing process

    Time frame: Throughout the trial (12-15 weeks)

    Semi-quantitatively measured (major improvement, minor improvement, status quo or worsening)

  4. Therapeutic doses of Botulinum toxin a to treat wound pain

    Time frame: 3 and 6 weeks after first injection

    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

  5. Incidence of Treatment-Emergent Adverse Events

    Time frame: Throughout the trial (12-15 weeks)

    All clinical adverse events will be assessed and recorded.

  6. 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

    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.

Other outcomes

  1. Wound status- Degree of inflammation, granulation tissue, necrosis/slough, exudation and infection.

    Time frame: Throughout the trial (12-15 weeks)

    Semi-quantitatively measured (Absent/Low < 25 %, Mild 25-50 %, Moderate 51-75 %, High > 75%)

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Official study title

The Effect of Subcutaneous Injection of Botulinum Toxin A on Chronic Wound Pain in Lower Extremities, a Prospective Exploratory Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 21, 2022
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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