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

Bispebjerg Hospital

Status and phase: Completed; Phase 4

Conditions: Chronic Pain; Lower Extremity Wound

Treatments: Drug: Botulinum Toxin A

Study type: Interventional

Funder types: Other

Identifiers

NCT05426161

Botox-01

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

2. Pregnant or lactating woman and woman with childbearing potential but does not use contraception.

3. Judgment by the investigator that the patient is not suited for study participation.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Botulinum Toxin A

Experimental group

Description:

Open-label study

Treatment:

Drug: Botulinum Toxin A