BridgeMD
Evaluation of Botulinum TOXin type A in the treatment of Buerger’s disease
EU CTIS ID: 2024-517772-38-00
What this study is testing
The primary judgment criterion is feasibility. 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.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years
- Patient with Buerger’s disease according to Olin criteria
- 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).
- Ability to attend study visits
- Ability to complete daily study agenda
- Ability to give free and informed consent
You likely can't join if
- History of myasthenia gravis or Eaton-Lambert syndrome
- Iloprost expected one month before the 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 BIOGARAN 5%, cream or NITROUS OXIDE MEDICINAL AIR LIQUIDE
- Patients treated by class III anti arythmic drugs for exemple amiodarone
See the full eligibility criteria
- Age ≥ 18 years
- Patient with Buerger’s disease according to Olin criteria
- 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).
- Ability to attend study visits
- Ability to complete daily study agenda
- Ability to give free and informed consent
- Membership of a Social Security scheme
- History of myasthenia gravis or Eaton-Lambert syndrome
- Iloprost expected one month before the 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 BIOGARAN 5%, cream or NITROUS OXIDE MEDICINAL AIR LIQUIDE
- Patients treated by class III anti arythmic drugs for exemple amiodarone
- Patient under guardianship, curatorship, protection of justice
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.