chronic wound pain and wound healing MedDRA version: 20.1 Level: LLT Classification code 10049542 Term: Wound pain System Organ Class: 100000004863
Conditions
Interventions
Trade Name: Botox
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Botulinum Toxin type A
CAS Number: 93384-43-1
Other descriptive name: BOTULINUM TOXIN TYPE A
Concentration
Sponsors
Department of Dermatology and Copenhagen Wound Healing Center, Bispebjerg Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age = 18 years old. Lower extremity ulcer = 4 weeks. Ulcer area = 0,5 cm2 and = 20 cm2. VAS pain scores = 30 mm. (Defined as mean VAS = 30 mm in the morning or afternoon at rest or movement measured over 3 consecutive days prior inclusion). Patients with neuropathic pain related to the ulcer (DN4 score = 4). 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 8 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: Infection at injection site. Hypersensitivity to botulinum toxin A. Peripheral neuropathy in the area of the wound judged by investigator. Unstable critic peripheral ischemia judged by investigator. Exposed capsule, tendon, muscle or bone in the ulcers. Tunnelling, undermining or sinus tracts. Disorders of the neuromuscular junction (e.g. Myasthenia). Topical analgesic (e.g Biatain ibu or Lidocain) within 4 days before inclusion. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the study is to investigate the effect of subcutaneous administration of Botulinum neurotoxin A on chronic wound pain and wound healing in lower extremity ulcer and safety of the treatment.;Secondary Objective: Not applicable;Primary end point(s): Difference in worst pain assessed on a visual analogue scale (VAS, 0–100 mm) at rest and DN4 questionnaire before and after injection of Botulinum neurotoxin Difference in the area (measured in cm2) of hyperalgesia and allodynia pre- and post-injection of Botulinum neurotoxin. Differences in wound area (measured in cm2) and clinical signs of healing pre- and post-injection of Botulinum neurotoxin Levels of inflammatory cytokines and markers in wound fluid pre- and post-injection of Botulinum neurotoxin. Levels of pain-related substances in wound fluid pre- and post-injection of Botulinum neurotoxin. ;Timepoint(s) of evaluation of this end point: Evaluation of end points will happen during the trial period (about 16 weeks for each patient) and when the laboratory analysis is completed (3-6 months after the end of the trial). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Therapeutic doses of Botulinum neurotoxin to treat wound pain. Safety of the treatment. ;Timepoint(s) of evaluation of this end point: Evaluation of end points will happen during the trial period (about 16 weeks for each patient). | — |
Countries
Denmark
Contacts
Public ContactLubna Sabah
Department of Dermatology and Copenhagen Wound Healing Center, Bispebjerg Hospital
Outcome results
None listed