Botulinum toxin type A - haemagglutinin complex for Buerger's disease

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years\n- Patient with Buerger’s disease according to Olin criteria\n- Patient 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).\n- Ability to attend study visits\n- Ability to complete daily study agenda\n- Ability to give free and informed consent\n- Membership of a Social Security scheme"}

Exclusion criteria

• {"criterion_text":"- History of myasthenia gravis or Eaton-Lambert syndrome\n- History of inflammatory myositis for less than 2 years or pre-existing motor neuron disease or superior limb neuropathy.\n- Known allergy to botulinum toxin or cream lidocaine, albumin or inhaled nitrous oxide/oxygen.\n- Progressive infection of one hand or foot\n- Aminoglycoside treatment\n- Pregnant or nursing women\n- History of vascular surgery of surgical sympathectomy of upper or lower limb\n- Revascularization procedure considered within 3 months of inclusion\n- Risk of major amputation within 3 months of inclusion\n- Iloprost expected one month before the study treatment\n- Hyperbaric chamber sessions scheduled within one month of study treatment\n- Life expectancy less than 6 months\n- Contraindication to one or more of the following products: BOTOX 100 UNITS ALLERGAN, LIDOCAINE/PRILOCAINE BIOGARAN 5%, cream or NITROUS OXIDE MEDICINAL AIR LIQUIDE\n- Patients treated by class III anti arythmic drugs for exemple amiodarone\n- Patient under guardianship, curatorship, protection of justice"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is feasibility. The feasibility endpoint corresponds to the number of patients who actually received the planned injections within the defined timeframes, among the patients who should have had the injection according to the protocol criteria.","definition_or_measurement_approach":"The feasibility endpoint 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 endpoints

• {"endpoint_text":"- Tolerance assessment. The tolerance criterion is assessed according to the practitioner by collecting temporary adverse events that are associated with the specific research procedure and that are expected and by severe adverse events.\n- Evaluation of critical ischemia parameters: Evaluation of tissue perfusion by laser Doppler, toe pressure or digital 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 partial oxygen pressure TCPO2 before (D0) and after injection (M1, M3, M6)\n- Pain assessment, evaluated by VAS at M1, M3, M6\n- Assessment of healing of distal ulcers (D0, M1, M3, M6) - color scale (% of bud, fibrin, necrosis, epidermization) at D0, M1, M3, M6 - size, surface of ulcers at D0, M1, M3, M6 - new distal ulcerations at D0, M1, M3, M6 - number of ulcers whose surface has reduced by more than 40% at M1, M3, M6 - number of total healing (100% epidermization) at M1, M3, M6 - number of minor or major amputations at M1, M3, M6\n- Appearance of new digital ulcers\n- Need for minor and major amputation\n- Frequency and severity of Raynaud's syndrome associated with Buerger's disease according to the Raynaud condition score (D0, M1, M3, M6) An attack is defined as a paroxysmal episode of pallor or cyanosis to cold (with or without pain, tingling or numbness). Patients will note daily the number and duration of RA attacks as well as the severity of the RA, each attack is self-assessed daily on a 10-point scale and the average calculated over the 14 days\n- Evaluation of quality of life questionnaires (EQ-5D-5L, Cochin, Claus) at D0 and M6","definition_or_measurement_approach":"Tolerance: collection of temporary adverse events associated with the procedure and severe adverse events (per practitioner).\nCritical ischemia parameters: tissue perfusion measured by laser Doppler, toe/digital pressure (mmHg), thermal camera imaging, transcutaneous partial oxygen pressure (TCPO2) at baseline (D0) and after injection (M1, M3, M6).\nPain: assessed by VAS at M1, M3, M6.\nUlcer healing: color scale (% granulation, fibrin, necrosis, epidermization), ulcer size/surface, new ulcerations, number with >40% surface reduction, number with complete healing (100% epidermization), and number of amputations at D0, M1, M3, M6.\nRaynaud's: frequency/severity via Raynaud condition score; patients self-record number/duration and severity daily (10-point scale), averaged over 14 days.\nQuality of life: questionnaires EQ-5D-5L, Cochin, Claus at D0 and M6."}

France

Earliest CTIS Part Ii Submission Date

01-10-2024

Latest Decision Or Authorization Date

22-10-2024

Processing Time Days

21

Number Of Sites

1

Number Of Participants

8

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Toulouse

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France