Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05698979 |
Other study ID # |
RC31/20/0445 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
Phase 3
|
First received |
|
Last updated |
|
Start date |
August 30, 2023 |
Est. completion date |
June 1, 2024 |
Study information
Verified date |
July 2023 |
Source |
University Hospital, Toulouse |
Contact |
Julie Malloizel-Delaunay, MD |
Phone |
05 61 32 30 33 |
Email |
malloizel-delaunay.j[@]chu-toulouse.fr |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
Buerger's disease or obliterate thromboangiitis(TAO) is a rare disease. It is an
inflammatory, segmental and occlusive disease affecting small and medium caliber arteries and
veins in the extremities of the limbs. It mainly affects young men, who traditionally smoke,
before the age of 45. There is currently no specific treatment for Buerger's disease.
Surgical treatment is rarely feasible, due to distal and diffuse damage. Several studies have
evaluated the perivascular injection of botulinum toxin type A (BTX) in patients with severe
Raynaud syndromes linked to scleroderma, with promising results.
Studies with BTX have shown reduced pain, improved tissue perfusion with laser doppler, and
healing of digital ulcers.
The patients are treated with a single session with botulinum toxin A injections during an
hospital visit, and the judgmental criteria are assessed at 1, 3 and 6 months post
injections.
The injections are made at 4 injection points at the palmar or distal plantar fold, at the
level of the neurovascular beams, 2h after topical anesthesia by lidocaine cream under
occlusion, associated or not with nitrous oxide inhaled at the time of the injections (BOTOX®
100 U, botulinum toxin A injections in each hand or foot, for a final dose of 50 U (1 ml) per
extremity).