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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05426161
Other study ID # Botox-01
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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