The effect of subcutaneous injection of Botulinum Toxin A on chronic wound pain in lower extremities, a prospective exploratory study

Phase 1

Conditions: chronic wound pain and wound healing
MedDRA version: 20.1Level: LLTClassification code 10049542Term: Wound painSystem Organ Class: 100000004863
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2021-000096-36-DK

Lead Sponsor: Department of Dermatology and Copenhagen Wound Healing Center, Bispebjerg Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 16

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

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.