Evaluation of Botulinum TOXin Type A in the Treatment of Buerger's Disease
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Feasibility in Number of patients
研究概览
简要总结
The main objective is to assess the feasibility of treatment by injecting botulinum toxin A into the hand or foot of patients with signs of critical ischemia secondary to Buerger's disease. The injection of botulinum toxin A is carried out at the end of a single session during an hospitalization. Furthermore, tolerance and effects on the disease are evaluated at 1, 3 and 6 months post injections.
详细描述
Buerger's disease or obliterate thromboangiitis(TAO) is a rare disease. It is an inflammatory, segmental and occlusive disease affecting small and medium caliber arteries and veins in the extremities of the limbs. It mainly affects young men, who traditionally smoke, before the age of 45. There is currently no specific treatment for Buerger's disease. Surgical treatment is rarely feasible, due to distal and diffuse damage. Several studies have evaluated the perivascular injection of botulinum toxin type A (BTX) in patients with severe Raynaud syndromes linked to scleroderma, with promising results.
Studies with BTX have shown reduced pain, improved tissue perfusion with laser doppler, and healing of digital ulcers.
The patients are treated with a single session with botulinum toxin A injections during an hospital visit, and the judgmental criteria are assessed at 1, 3 and 6 months post injections.
The injections are made at 4 injection points at the palmar or distal plantar fold, at the level of the neurovascular beams, 2h after topical anesthesia by lidocaine cream under occlusion, associated or not with nitrous oxide inhaled at the time of the injections (BOTOX® 100 U, botulinum toxin A injections in each hand or foot, for a final dose of 50 U (1 ml) per extremity).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •patient with Buerger's disease according to Olin criteria (ref)
- •with digital ischemia with critical upper or lower limb ischemia criteria defined as Upper limb: pain and/or trophic disorders for at least 15 days AND digital pressure less than 50 mmHg Or TCPO2 30 mmHg) Or/and Lower limb: pain and/or trophic disorders for at least 15 days AND ankle pressure less than 50 mmHg (70 mmHg if diabetes), or 30 mmHg at the toe (50 mmHg if diabetes) or TCPO2 30 mmHg).
- •Ability to attend study visits
- •Ability to complete daily study agenda
- •Ability to give free and informed consent
- •Membership of a Social Security scheme
排除标准
- •History of myasthenia gravis or Eaton-Lambert syndrome
- •History of inflammatory myositis for less than 2 years or pre-existing motor neuron disease or superior limb neuropathy.
- •Known allergy to botulinum toxin or cream lidocaine, albumin or inhaled nitrous oxide/oxygen.
- •Progressive infection of one hand or foot
- •Aminoglycoside treatment
- •Pregnant or nursing women
- •History of vascular surgery of surgical sympathectomy of upper or lower limb
- •Revascularization procedure considered within 3 months of inclusion
- •Risk of major amputation within 3 months of inclusion
- •Iloprost expected within one month of study treatment
- •Hyperbaric chamber sessions scheduled within one month of study treatment
- •Life expectancy less than 6 months
- •Contraindication to one or more of the following products: BOTOX 100 UNITS ALLERGAN, LIDOCAINE/PRILOCAINE 5%, cream or NITROUS OXIDE MEDICINAL
- •Patients treated by class III anti arhythmic drugs for example amiodarone 15 ) Patient with guardians, curators, or protection of justice
研究组 & 干预措施
drug administration
Botox Injection
干预措施: BOTOX INJECTION (Drug)
结局指标
主要结局
Feasibility in Number of patients
时间窗: through study completion, an average of 18 months
The feasibility criterion corresponds to the number of patients who actually received the planned injections within the defined time limits, among the patients who should have received the injection according to the criteria of the protocol.
次要结局
- tolerance of participants(2 hours after injection)
- tolerance after injection(2 hours after injection)
- tolerance during injection(during injection)