This study assesses the feasibility and safety of treatment with botulinum toxin injection in patients with Buerger's disease
Conditions
Interventions
Trade Name: Botulinum toxin type A
Pharmaceutical Form: Injection
Sponsors
CHU de Toulouse
Eligibility
Sex/Gender
All
Inclusion criteria
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 (3) Upper limb: pain and/or trophic disorders for at least 15 days AND digital pressure less than 50 mmHg Or TCPO2 30 mmHg) 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 7 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 7
Exclusion criteria
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) Pregnant or nursing women 6) History of vascular surgery of surgical sympathectomy of upper or lower limb 7) Risk of major amputation within 3 months of inclusion 8) Iloprost expected within one month of study treatment 9) hyperbaric chamber sessions scheduled within one month of study treatment 10) life expectancy less than 6 months 11) Cognitive impairment 12) Patient under guardianship, curatorship, protection of justice
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to assess the feasibility and safety of treatment by injecting botulinum toxin A into each hand or foot of patients with signs of critical ischemia secondary to Buerger's disease. The injection of botulinum toxin A into each hand or foot is performed after a single session, in day hospitalization. Tolerance is assessed before, during and 2 hours after the injection. ;Secondary Objective: The secondary objective is to assess the impact of the injection of botulinum toxin A in each hand or foot at the end of a session, at 1 month, 3 months and 6 months on: - critical hemodynamic ischemia parameters (toe pressure or finger pressure, TCPO2 - the intensity of the pain (VAS) - healing of distal ulcers -the number of new digital ulcers - the number of minor or major amputations, - the frequency and severity of Raynaud's syndrome associated with Buerger's disease - life quality ;Primary end point(s): The primary endpoint is feasibility as well as tolerance. The feasibility criterion corresponds to the number of patients who actually received the injections planned within the defined timeframes, compared to the number of patients who should have had the injection according to the criteria of the protocol. ;Timepoint(s) of evaluation of this end point: 6 months after injection Botulinum toxin | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1 / Critical ischemia parameters: Doppler laser tissue perfusion assessment, toe pressure or finger pressure in mmHg before (D0) and after injection (M1, M3, M6) Evaluation of tissue perfusion by thermal camera before (D0) and after injection (M1, M3, M6) Transcutaneous measurement of the partial pressure of oxygen TCPO2 before (J0) and after injection (M1, M3, M6) 2 / Pain assessed by the EVA at M1, M3, M6 3 / Evaluation of the healing of distal ulcers (D0, M1, M3, M6) - color scale (% of bud, fibrin, necrosis, epidemization) at D0, M1, M3, M6 - dimension, surface of ulcers at D0, M1, M3, M6 - new distal ulcerations on D0, M1, M3, M6 - number of ulcers whose surface area has reduced by more than 40% at M1, M3, M6 - number of total healing (100% epidermis) at M1, M3, M6 - number of minor or major amputations at M1, M3, M6 4 / Appearance of new digital ulcers 5 / Need for minor and major amputation 6 / Frequency and severity of Raynaud's syndrome associated with Buerger's disease according to the Raynaud condition score (J0, M1, M3, M6) A seizure is defined as a paroxysmal episode of pallor or cold cyanosis (with or without pain, tingling or numbness). Patients will note the number and duration of RA attacks on a daily basis as well as the severity of the RA, each attack is self-assessed daily on a 10-point scale and the average calculated over 14 days ± 4 days, from day D-14 to day D0 (+/- 4 days) and from day D14 to day D28 (+/- 4 days) 7 / Quality of life questionnaire (EQ-5D-5L, Cochin, Claus) on D0 and M6 ;Timepoint(s) of evaluation of this end point: 6 months after injection Botulinum toxin | — |
Countries
France
Contacts
Public ContactClinical Research Associate
CHU de Toulouse
Outcome results
None listed