Not yet recruiting NCT05698979

Evaluation of Botulinum TOXin Type A in the Treatment of Buerger's Disease

Phase III Interventional Buerger Disease Raynaud Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: BOTOX INJECTION.
Who it may be relevant to: Registry conditions: Buerger Disease, Raynaud Syndrome. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: France
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Detailed description

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).

Interventions

Drug BOTOX INJECTION
The patient will be treated with a single session with botulinum toxin A injections at the hospital, and the judgmental criteria will be assessed at 1, 3 and 6 months post injections. The injections will be made in 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). In the event of multiple lesio

Primary outcome measures

Feasibility in Number of patients [Time frame: through study completion, an average of 18 months]

Secondary outcome measures (4)

tolerance of participants [Time frame: during injection]
tolerance of participants [Time frame: 2 hours after injection]
tolerance during injection [Time frame: during injection]
tolerance after injection [Time frame: 2 hours after injection]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Treatment

Study locations

France · 1 center

University Hospital Toulouse — Toulouse

Identifiers

NCT: NCT05698979 · RC31/20/0445

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗