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

NCT05426161 | Completed Phase 4 DMC

• 1 other identifier: Botox-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Lower Extremity Wound

Keywords

Botulinum toxin A

Outcome Measures

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

  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

  3 to 6 weeks after first injection of Botulinum toxin a

Secondary Outcomes (6)

• Absolute and percentage change in the area of hyperalgesia and allodynia

  3 to15 weeks after first injection of Botulinum toxin a.

• Absolute and percentage change of the ulcer area.

  Throughout the trial (12-15 weeks)

• Clinical improvement of the wound healing process

  Throughout the trial (12-15 weeks)

• Therapeutic doses of Botulinum toxin a to treat wound pain

  3 and 6 weeks after first injection

• Incidence of Treatment-Emergent Adverse Events

  Throughout the trial (12-15 weeks)

Other Outcomes (1)

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

  Throughout the trial (12-15 weeks)

Study Arms (1)

Botulinum Toxin A

EXPERIMENTAL

Open-label study

Drug: Botulinum Toxin A

Interventions

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.

Botulinum Toxin A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Bispebjerg Hospital: lead

Study Sites (1)

Department of Dermatology and Copenhagen Wound Healing Center, Bispebjerg Hospital

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Simon Francis Thomsen, Professor

  Department of Dermatology and Copenhagen Wound Healing Center, Bispebjerg Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator, MD

Model Details: A single-center, prospective, exploratory study

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 21, 2022
• Study Start: February 7, 2023
• Primary Completion: April 23, 2024
• Study Completion: April 23, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)