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

Department of Dermatology and Copenhagen Wound Healing Center, Bispebjerg Hospital0 个研究点目标入组 16 人开始时间: 2021年2月4日最近更新: 2024年5月21日

适应症

试验速览

暂无简介。

•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

•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.

发起方

Department of Dermatology and Copenhagen Wound Healing Center, Bispebjerg Hospital