Effect of Blood Flow by Botulinum Toxin Injection for Severe Peripheral Artery Occlusive Disease

Launched by YONSEI UNIVERSITY · Mar 11, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how well an injection of botulinum toxin A can help heal wounds on the lower legs of people who have poor blood flow, a condition known as lower extremity ischemia. The main goal is to see if this treatment can improve healing for patients who have chronic ulcers that aren't responding to other treatments. The trial is currently recruiting participants who are at least 20 years old and have a wound between 1x1 cm and 3x3 cm in size.

To be eligible for the study, participants need to have moderate to severe lower extremity ischemia and should not be able to undergo other procedures to improve blood flow, like angioplasty. Participants will need to be able to follow the study's requirements and provide written consent to join. Those who have certain neurological conditions, are taking specific medications, or have recently used other treatments for their wound may not qualify. If you or a loved one is interested in this study, it could be a chance to explore a new potential treatment for difficult-to-heal wounds.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 20 years old
• • 2. Patients who have a lower extremity wound among those who have been diagnosed with moderate or severe lower extremity ischemia
• • 3. Patients who are unable to perform additional procedures (angioplasty, etc.) by performing peripheral vascular examination and CT angiography
• • 4. Wound size ≥ 1x1cm2 to ≤ 3x3cm2
• • 5. Patients who can follow the clinical trial procedure well and abide by the visit schedule
• • 6. Written informed consent to participate in the study after having fully understood the contents of the protocol and restrictions.
• Exclusion Criteria:
• • 1. Patients with diseases that can affect neuromuscular function, such as myasthenia gravis, Eaton-Lamberton syndrome, amyotrophic lateral sclerosis, and motor neuropathy
• • 2. Within 4 weeks before screening, aminoglycoside antibiotics, curare-like agents, or drugs that inhibit neuromuscular function (muscle relaxants, anticholinergics, benzodiazepines, benzamides, tetracyclines, Rinco Those who have taken mycin antibiotics, etc.)
• • 3. Those taking aspirin, NSAIDs or anticoagulants within 7 days before screening
• • 4. Those who have received botulinum toxin preparations within 3 months before screening
• • 5. Angiography or CT angiography If one or more of the three major blood vessels in the lower extremity are open
• • 6. Cases in which blood flow to the lower extremities can be preserved by performing balloon angioplasty even if all three major blood vessels in the lower extremity are blocked
• • 7. Those who are currently taking steroids or immunosuppressants that affect wounds, or those who have taken them within one month of screening
• • 8. Those who have applied injection drugs or wound coverings that help improve wounds within 1 week of screening
• • 9. Women who are pregnant, lactating, planning to become pregnant during the clinical period, or women of childbearing age who are not using available contraceptive methods (women of childbearing age must be negative in the pregnancy test prior to injection).
• • 10. Those who are allergic or sensitive to botulinum toxin
• • 11. Those who have participated in another clinical trial within 30 days before screening or those who have not passed the half-life of the investigational product of the clinical trial that they participated in, whichever is longer.
• • 12. Those who are not suitable for this clinical trial under the judgment of other investigators