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

NCT05698979 | Not Yet Recruiting Phase 3

• 1 other identifier: RC31/20/0445
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Buerger Disease; Raynaud Syndrome

Keywords

botulinum toxin A; botox; feasibility; raynaud; buerger; tolerance

Outcome Measures

Primary Outcomes (1)

• 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.

  through study completion, an average of 18 months

Secondary Outcomes (4)

• tolerance of participants

  during injection

• tolerance of participants

  2 hours after injection

• tolerance during injection

  during injection

• tolerance after injection

  2 hours after injection

Study Arms (1)

drug administration

EXPERIMENTAL

Botox Injection

Drug: BOTOX INJECTION

Interventions

BOTOX INJECTION DRUG

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).

Also known as: botulinum toxin

drug administration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Related Links

• Related Info

MeSH Terms

Conditions

Thromboangiitis Obliterans; Raynaud Disease

Interventions

Botulinum Toxins

Condition Hierarchy (Ancestors)

Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Vasculitis; Livedoid Vasculopathy; Thrombosis; Embolism and Thrombosis; Peripheral Vascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Julie Malloizel-Delaunay, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Malloizel-Delaunay, MD

CONTACT

05 61 32 30 33; malloizel-delaunay.j@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2023
• First Posted: January 26, 2023
• Study Start: January 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share