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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05426161
• Other study ID #: Botox-01
• Status: Recruiting
• Phase: Phase 4
• Start date: February 7, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: February 2023
• Source: Bispebjerg Hospital
• Contact: Lubna Sabah, MD
• Phone: +4529466632
• Email: lubna.sabah[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: December 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Lower Extremity Wound
• Wounds and Injuries

Intervention

Drug:
• Botulinum Toxin A
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.

Locations

Country	Name	City	State
Denmark	Department of Dermatology and Copenhagen Wound Healing Center, Bispebjerg Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Wound status- Degree of inflammation, granulation tissue, necrosis/slough, exudation and infection.	Semi-quantitatively measured (Absent/Low < 25 %, Mild 25-50 %, Moderate 51-75 %, High > 75%)	Throughout the trial (12-15 weeks)
Primary	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	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	3 to15 weeks after first injection of Botulinum toxin a.
Secondary	Absolute and percentage change of the ulcer area.	The ulcer size will be measured at every visit with study day 0 as baseline.	Throughout the trial (12-15 weeks)
Secondary	Clinical improvement of the wound healing process	Semi-quantitatively measured (major improvement, minor improvement, status quo or worsening)	Throughout the trial (12-15 weeks)
Secondary	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	3 and 6 weeks after first injection
Secondary	Incidence of Treatment-Emergent Adverse Events	All clinical adverse events will be assessed and recorded.	Throughout the trial (12-15 weeks)
Secondary	Exploratory measurement: Changes in the levels of cytokines and pain related substances in the wound fluid before and after injection with Botulinum toxin a	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-1ß) with either MSD,Luminex or ELISA.; The results will be expressed as pg/ mg.	Analysis within 1 year after study completion