Actively Recruiting
Effect of Blood Flow by Botulinum Toxin Injection for Severe Peripheral Artery Occlusive Disease
Led by Yonsei University · Updated on 2025-03-17
15
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Blood Flow by Botulinum Toxin Injection for Severe Peripheral Artery Occlusive Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 20 years or older
- Diagnosed with moderate or severe lower extremity ischemia and have a lower leg wound
- Unable to undergo additional procedures like angioplasty after vascular exams and CT angiography
- Wound size between 1x1 cm and 3x3 cm
- Able to follow the clinical trial procedures and visit schedule
- Provided written informed consent after understanding the study protocol
You will not qualify if you...
- Diseases affecting neuromuscular function such as myasthenia gravis, Eaton-Lamberton syndrome, amyotrophic lateral sclerosis, or motor neuropathy
- Use of aminoglycoside antibiotics, muscle relaxants, anticholinergics, benzodiazepines, benzamides, tetracyclines, or similar drugs within 4 weeks before screening
- Use of aspirin, NSAIDs, or anticoagulants within 7 days before screening
- Received botulinum toxin treatment within 3 months before screening
- One or more of the three major lower leg blood vessels are open on angiography or CT angiography
- Blood flow can be preserved by balloon angioplasty even if all three major lower leg vessels are blocked
- Use of steroids or immunosuppressants affecting wounds currently or within 1 month before screening
- Use of injection drugs or wound coverings that improve wounds within 1 week before screening
- Women who are pregnant, breastfeeding, planning pregnancy during the study, or women of childbearing age not using contraception
- Allergy or sensitivity to botulinum toxin
- Participation in another clinical trial within 30 days before screening or not past the investigational product's half-life
- Deemed unsuitable for the trial by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Yongin Severance Hospital
Yongin-si, Gyeonggi-do, South Korea, 16995
Actively Recruiting
Research Team
H
Hiisun J, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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