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Botox shots aim to save limbs in rare Smoker's disease

NCT ID NCT05698979

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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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.