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The Effect of Subcutaneous Injection of Botulinum Toxin A on Chronic Wound Pain in Lower Extremities | Clinical Trials | Clareo Health

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

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

NCT05426161•Bispebjerg Hospital

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

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.
•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

Key Dates

Start Date

February 7, 2023

Primary Completion Date

April 23, 2024

Completion Date

April 23, 2024

Last Updated

August 9, 2024

Enrollment

ACTUAL participants

Conditions

Chronic PainLower Extremity Wound

Interventions

Botulinum Toxin A

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 9, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

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