Status:
RECRUITING
Effect of Blood Flow by Botulinum Toxin Injection for Severe Peripheral Artery Occlusive Disease
Lead Sponsor:
Yonsei University
Conditions:
Chronic Ulcer of Lower Extremity
Wound
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to investigate the effect of subcutaneous injection of botulinum toxin A on wound healing caused by lower extremity ischemia.
Detailed Description
Tissues below the calf are governed by blood flow from the anterior tibial artery, peroneal artery, and posterior tibial artery. When an ulcer occurs due to acute lower extremity ischemia, one of the ...
Eligibility Criteria
Inclusion
- Age ≥ 20 years old
- Patients who have a lower extremity wound among those who have been diagnosed with moderate or severe lower extremity ischemia
- Patients who are unable to perform additional procedures (angioplasty, etc.) by performing peripheral vascular examination and CT angiography
- Wound size ≥ 1x1cm2 to ≤ 3x3cm2
- Patients who can follow the clinical trial procedure well and abide by the visit schedule
- Written informed consent to participate in the study after having fully understood the contents of the protocol and restrictions.
Exclusion
- Patients with diseases that can affect neuromuscular function, such as myasthenia gravis, Eaton-Lamberton syndrome, amyotrophic lateral sclerosis, and motor neuropathy
- 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.)
- Those taking aspirin, NSAIDs or anticoagulants within 7 days before screening
- Those who have received botulinum toxin preparations within 3 months before screening
- Angiography or CT angiography If one or more of the three major blood vessels in the lower extremity are open
- 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
- Those who are currently taking steroids or immunosuppressants that affect wounds, or those who have taken them within one month of screening
- Those who have applied injection drugs or wound coverings that help improve wounds within 1 week of screening
- 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).
- Those who are allergic or sensitive to botulinum toxin
- 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.
- Those who are not suitable for this clinical trial under the judgment of other investigators
Key Trial Info
Start Date :
April 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06878482
Start Date
April 17 2023
End Date
March 31 2026
Last Update
March 17 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Yongin Severance Hospital
Yongin-si, Gyeonggi-do, South Korea, 16995