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

Bispebjerg Hospital10 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Pain Lower Extremity Wound

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of Dermatology and Copenhagen Wound Healing Center, Bispebjerg Hospital

Copenhagen, Denmark

Outcomes

Primary Outcomes

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

Time frame: 3 to 6 weeks after first injection of Botulinum toxin a

Secondary Outcomes

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

Time frame: 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.

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

Clinical improvement of the wound healing process

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

Time frame: 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

Time frame: 3 and 6 weeks after first injection

Incidence of Treatment-Emergent Adverse Events

All clinical adverse events will be assessed and recorded.

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

Data from ClinicalTrials.gov

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