Raynaud Syndrome Clinical Trial
— BETOXOfficial title:
Evaluation of Botulinum TOXin Type A in the Treatment of Buerger's Disease
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.
Status | Not yet recruiting |
Enrollment | 8 |
Est. completion date | June 1, 2024 |
Est. primary completion date | June 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age = 18 years 2. patient with Buerger's disease according to Olin criteria (ref) 3. 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). 4. Ability to attend study visits 5. Ability to complete daily study agenda 6. Ability to give free and informed consent 7. Membership of a Social Security scheme Exclusion Criteria: 1. History of myasthenia gravis or Eaton-Lambert syndrome 2. History of inflammatory myositis for less than 2 years or pre-existing motor neuron disease or superior limb neuropathy. 3. Known allergy to botulinum toxin or cream lidocaine, albumin or inhaled nitrous oxide/oxygen. 4. Progressive infection of one hand or foot 5. Aminoglycoside treatment 6. Pregnant or nursing women 7. History of vascular surgery of surgical sympathectomy of upper or lower limb 8. Revascularization procedure considered within 3 months of inclusion 9. Risk of major amputation within 3 months of inclusion 10. Iloprost expected within one month of study treatment 11. Hyperbaric chamber sessions scheduled within one month of study treatment 12. Life expectancy less than 6 months 13. Contraindication to one or more of the following products: BOTOX 100 UNITS ALLERGAN, LIDOCAINE/PRILOCAINE 5%, cream or NITROUS OXIDE MEDICINAL 14. Patients treated by class III anti arhythmic drugs for example amiodarone 15 ) Patient with guardians, curators, or protection of justice |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University Hospital, Toulouse |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | tolerance of participants | collection of temporary low grade adverse events (hematoma, erythema, ecchymosis at the injection site, pain, before/after and during injection) | during injection | |
Secondary | tolerance of participants | collection of temporary low grade adverse events (hematoma, erythema, ecchymosis at the injection site, pain, before/after and during injection) | 2 hours after injection | |
Secondary | 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) | during injection | |
Secondary | 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) | 2 hours after injection |
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