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

Primary Purpose

Buerger Disease, Raynaud Syndrome

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
BOTOX INJECTION
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Buerger Disease focused on measuring botulinum toxin A, botox, feasibility, raynaud, buerger, tolerance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    drug administration

    Arm Description

    Botox Injection

    Outcomes

    Primary Outcome Measures

    Feasibility in Number of patients
    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.

    Secondary Outcome Measures

    tolerance of participants
    collection of temporary low grade adverse events (hematoma, erythema, ecchymosis at the injection site, pain, before/after and during injection)
    tolerance of participants
    collection of temporary low grade adverse events (hematoma, erythema, ecchymosis at the injection site, pain, before/after and during injection)
    tolerance during injection
    collection of temporary high grade adverse events (muscle weakness, temporary or prolonged headache, general muscle weakness or muscle group at distance from injection site, difficulty swallowing, dyspnea, immediate allergic reaction to injections)
    tolerance after injection
    collection of temporary high grade adverse events (muscle weakness, temporary or prolonged headache, general muscle weakness or muscle group at distance from injection site, difficulty swallowing, dyspnea, immediate allergic reaction to injections)

    Full Information

    First Posted
    January 5, 2023
    Last Updated
    July 10, 2023
    Sponsor
    University Hospital, Toulouse
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05698979
    Brief Title
    Evaluation of Botulinum TOXin Type A in the Treatment of Buerger's Disease
    Acronym
    BETOX
    Official Title
    Evaluation of Botulinum TOXin Type A in the Treatment of Buerger's Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 30, 2023 (Anticipated)
    Primary Completion Date
    June 1, 2024 (Anticipated)
    Study Completion Date
    June 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Toulouse

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Buerger Disease, Raynaud Syndrome
    Keywords
    botulinum toxin A, botox, feasibility, raynaud, buerger, tolerance

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    8 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    drug administration
    Arm Type
    Experimental
    Arm Description
    Botox Injection
    Intervention Type
    Drug
    Intervention Name(s)
    BOTOX INJECTION
    Other Intervention Name(s)
    botulinum toxin
    Intervention Description
    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 lesions, a single limb is injected based on clinical severity (ulcer, gangrene) and ischemia parameters (lowest TCPO2).
    Primary Outcome Measure Information:
    Title
    Feasibility in Number of patients
    Description
    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.
    Time Frame
    through study completion, an average of 18 months
    Secondary Outcome Measure Information:
    Title
    tolerance of participants
    Description
    collection of temporary low grade adverse events (hematoma, erythema, ecchymosis at the injection site, pain, before/after and during injection)
    Time Frame
    during injection
    Title
    tolerance of participants
    Description
    collection of temporary low grade adverse events (hematoma, erythema, ecchymosis at the injection site, pain, before/after and during injection)
    Time Frame
    2 hours after injection
    Title
    tolerance during injection
    Description
    collection of temporary high grade adverse events (muscle weakness, temporary or prolonged headache, general muscle weakness or muscle group at distance from injection site, difficulty swallowing, dyspnea, immediate allergic reaction to injections)
    Time Frame
    during injection
    Title
    tolerance after injection
    Description
    collection of temporary high grade adverse events (muscle weakness, temporary or prolonged headache, general muscle weakness or muscle group at distance from injection site, difficulty swallowing, dyspnea, immediate allergic reaction to injections)
    Time Frame
    2 hours after injection

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Julie Malloizel-Delaunay, MD
    Phone
    05 61 32 30 33
    Email
    malloizel-delaunay.j@chu-toulouse.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Julie Malloizel-Delaunay, MD
    Organizational Affiliation
    University Hospital, Toulouse
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Links:
    URL
    https://www.has-sante.fr/upload/docs/application/pdf/AOMI_recos.pdf
    Description
    Related Info

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

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