Evaluation of Botulinum TOXin Type A in the Treatment of Buerger's Disease (NCT05698979) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Evaluation of Botulinum TOXin Type A in the Treatment of Buerger's Disease
8 participantsStarted 2027-01-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 3 trial for Buerger's disease using Botulinum Toxin Type A injections — how does that treatment approach compare to what's currently available for managing my condition, and would it make sense to try standard options first?
2The trial is listed as 'not yet recruiting' — do you know when it might open, and is it realistic for me to wait to see if I qualify, or should we focus on other treatment plans in the meantime?
3Since the primary thing this trial is measuring is the number of patients they can enroll rather than a direct treatment outcome, what does that tell us about how much we'd learn about whether the treatment actually works for someone in my situation?
4Buerger's disease often involves serious circulation problems in the hands and feet — how would injecting Botulinum Toxin Type A into those areas work, and what risks should I be aware of given that my circulation is already compromised?
5This trial also includes people with Raynaud Syndrome — does that mean it's designed for a range of severity levels, and how would my doctor decide whether my specific case of Buerger's disease is the right fit for what this study is testing?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility in Number of patients
Timeframe: through study completion, an average of 18 months