RecruitingPhase 4NCT06878482

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

Effect of Increasing Blood Flow by Botulinum Toxin Local Injection for Severe Peripheral Artery Occlusive Disease: Preliminary Report

Sponsor

Yonsei University

Enrollment

15 participants

Start Date

Apr 17, 2023

Study Type

INTERVENTIONAL

Conditions

Wound Blood Circulation Botulinum Toxins, Type A Chronic Ulcer of Lower Extremity

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.

Eligibility

Min Age: 20 Years

Inclusion Criteria6

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 Criteria12

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