Botox shots aim to save limbs in rare Smoker's disease
NCT ID NCT05698979
First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 2 times
Summary
This study tests whether injecting botulinum toxin (Botox) into the hands or feet can help people with Buerger's disease, a rare condition that blocks blood flow and causes severe pain. Eight adults with critical limb ischemia will receive a single injection session and be followed for 6 months. The main goal is to see if the procedure is feasible and safe, with secondary checks on pain and healing.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
About 8 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Jan 2027
An estimate. Start dates often move.
- Expected to finish
-
Feb 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Buerger disease are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
University Hospital Toulouse
Toulouse, CHU de Toulouse, 31059, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.