Effect of botulinum toxin A on vasoconstriction and sympathetic neurotransmitters in a murine random pattern skin flap model.
Tai Suk Roh, Bok Ki Jung, Insik Yun...
https://pubmed.ncbi.nlm.nih.gov/27997734Actively Recruiting
Phase 4
Age: 20Years +
All Genders
ID06878482
Effect of Increasing Blood Flow by Botulinum Toxin Local Injection for Severe Peripheral Artery Occlusive Disease: Preliminary Report
Led by Yonsei University · Updated on 2025-03-17
15
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how subcutaneous injections of botulinum toxin A affect healing of wounds caused by lower extremity ischemia, a condition where blood flow to the legs is reduced or blocked. This condition often affects elderly patients or those with diabetes, causing chronic wounds or ulcers due to narrowed or blocked blood vessels. The study focuses on patients with wounds on their feet where blood circulation relies mainly on collateral vessels.
CONDITIONS
Brief Title
Effect of Blood Flow by Botulinum Toxin Injection for Severe Peripheral Artery Occlusive Disease
Who Can Participate
Age: 20Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 20 years or older
- Diagnosed with moderate or severe lower extremity ischemia with a wound on the lower leg or foot
- Unable to perform additional procedures like angioplasty based on vascular exams and CT angiography
- Wound size between 1x1 cm and 3x3 cm
- Able to follow the trial procedures and visit schedule
- Provided written informed consent after understanding the study and restrictions
You will not qualify if you...
- Diseases affecting neuromuscular function such as myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or motor neuropathy
- Use of aminoglycoside antibiotics, muscle relaxants, or drugs inhibiting neuromuscular function within 4 weeks before screening
- Use of aspirin, NSAIDs, or anticoagulants within 7 days before screening
- Received botulinum toxin injections within 3 months before screening
- One or more major lower leg blood vessels open on angiography or CT angiography
- Blood flow preserved by balloon angioplasty despite blocked vessels
- Current or recent use (within 1 month) of steroids or immunosuppressants affecting wounds
- Applied injection drugs or wound coverings to improve wounds within 1 week before screening
- Pregnant, lactating, planning pregnancy, or women of childbearing age not using contraception
- Allergic or sensitive to botulinum toxin
- Participation in another clinical trial within 30 days before screening or within the investigational product half-life
- Judged unsuitable for the trial by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 14 days
Participants receive a subcutaneous injection of Botulinum toxin A in and around the wound to improve blood flow and promote wound healing.
Visits at baseline, 7 days, and 14 days after injection
Trial Site Locations
Total: 1 location
1
Yongin Severance Hospital
Yongin-si, Gyeonggi-do, South Korea, 16995
Actively Recruiting
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Research Team
H
Hiisun J, Dr
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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